{"id":3973,"date":"2021-10-30T01:00:00","date_gmt":"2021-10-30T01:00:00","guid":{"rendered":"https:\/\/relish.quhenet.com\/?p=3973"},"modified":"2026-10-20T05:26:35","modified_gmt":"2026-10-20T05:26:35","slug":"%e3%82%a6%e3%82%a9%e3%83%bc%e3%82%bf%e3%83%bc%e3%83%95%e3%83%ad%e3%83%83%e3%82%b5%e3%83%bc%e3%81%af%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%a7%e3%81%99","status":"publish","type":"post","link":"https:\/\/relish-tech.com\/jp\/is-the-water-flosser-a-medical-device\/","title":{"rendered":"\u53e3\u8154\u6d17\u6d44\u5668\u306f\u533b\u7642\u6a5f\u5668\uff1f\u7c73\u56fd\u5e02\u5834\u53c2\u5165\u306b\u95a2\u3059\u308bFDA\u898f\u5247"},"content":{"rendered":"<style id=\"relish-history-3973-ui\">\nbody.postid-3973 .elementor-widget-theme-post-content.elementor-element-d2b9469{font-family:Poppins,sans-serif;font-size:18px;line-height:30.6px;color:#252827;overflow-wrap:break-word}\nbody.postid-3973 .elementor-widget-theme-post-content.elementor-element-d2b9469 > p{font-size:18px;line-height:30.6px;margin:0 0 20px;color:#252827}\nbody.postid-3973 .elementor-widget-theme-post-content.elementor-element-d2b9469 > h2{font-size:28px;line-height:39px;font-weight:700;color:#005746;margin:36px 0 18px;text-wrap:pretty;scroll-margin-top:100px}\nbody.postid-3973 .elementor-widget-theme-post-content.elementor-element-d2b9469 > figure.wp-block-image{max-width:100%;margin:24px 0}\nbody.postid-3973 .elementor-widget-theme-post-content.elementor-element-d2b9469 > figure.wp-block-image img{display:block;max-width:100%;width:auto;height:auto;margin:0 auto;border-radius:8px}\nbody.postid-3973 .elementor-widget-theme-post-content.elementor-element-d2b9469 > p:nth-of-type(3) > br{display:none}\n@media(max-width:767px){body.postid-3973 .elementor-widget-theme-post-content.elementor-element-d2b9469 > p{font-size:16px;line-height:28px}body.postid-3973 .elementor-widget-theme-post-content.elementor-element-d2b9469 > h2{font-size:24px;line-height:34px;margin-top:30px}body.postid-3973 .elementor-widget-theme-post-content.elementor-element-d2b9469 > figure.wp-block-image{margin:20px 0}}\n<\/style>\n\n<article class=\"relish-fda-water-flosser-article\">\n<p>\u7c73\u56fd\u3067\u306f\u3001FDA\u306f\u53e3\u8154\u6d17\u6d44\u5668\u3092\u88fd\u54c1\u30b3\u30fc\u30c9EFS\u306e\u30af\u30e9\u30b9I\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u63b2\u8f09\u3057\u3066\u3044\u307e\u3059\u3002\u53e3\u8154\u6d17\u6d44\u5668\u304c\u3053\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u8a72\u5f53\u3059\u308b\u304b\u306f\u3001\u4f7f\u7528\u76ee\u7684\u3001\u8a2d\u8a08\u3001\u8868\u793a\u30fb\u5e83\u544a\u4e0a\u306e\u8a34\u6c42\u306b\u3088\u3063\u3066\u6c7a\u307e\u308a\u307e\u3059\u3002\u767b\u9332\u304c\u5fc5\u8981\u306a\u5834\u5408\u3067\u3082\u3001\u767b\u9332\u306fFDA\u306e\u627f\u8a8d\u3068\u306f\u7570\u306a\u308a\u307e\u3059\u3002<\/p>\n\n<h2>FDA\u306e\u5206\u985e\u304b\u3089\u308f\u304b\u308b\u3053\u3068<\/h2>\n\n<p>\u53e3\u8154\u6d17\u6d44\u5668\u306f\u3001\u6b6f\u9593\u3084\u6b6f\u3068\u6b6f\u3050\u304d\u306e\u5883\u76ee\u306b\u6cbf\u3063\u3066\u6c34\u3092\u5674\u5c04\u3057\u307e\u3059\u3002\u898f\u5236\u4e0a\u306e\u5224\u65ad\u3067\u306f\u3001\u6d17\u6d44\u65b9\u5f0f\u3060\u3051\u3067\u306a\u304f\u3001\u5b8c\u6210\u54c1\u3068\u305d\u306e\u4f7f\u7528\u76ee\u7684\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/p>\n\n<p>FDA\u306e\u533b\u7642\u6a5f\u5668\u5206\u985e\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3067\u306f\u3001\u53e3\u8154\u6d17\u6d44\u5668\u306f\u88fd\u54c1\u30b3\u30fc\u30c9EFS\u306b\u5206\u985e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u9805\u76ee\u306f\u30af\u30e9\u30b9I\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u3092\u793a\u3057\u3001\u6a5f\u5668\u3068\u7528\u9014\u306b\u9069\u7528\u3055\u308c\u308b\u5236\u9650\u306e\u7bc4\u56f2\u5185\u3067\u3001\u901a\u5e38\u306f510(k)\u5e02\u8ca9\u524d\u5c4a\u51fa\u304c\u514d\u9664\u3055\u308c\u307e\u3059\u3002<\/p>\n\n<!-- Preserved existing figure: media 3976 -->\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1536\" height=\"1024\" src=\"https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/water-flosser-home-travel-formats.webp\" alt=\"\u6d74\u5ba4\u306e\u636e\u3048\u7f6e\u304d\u578b\u53e3\u8154\u6d17\u6d44\u5668\u3068\u3001\u65c5\u884c\u7528\u30dd\u30fc\u30c1\u306e\u6a2a\u306b\u7f6e\u3044\u305f\u643a\u5e2f\u578b\u53e3\u8154\u6d17\u6d44\u5668\u306e\u30a4\u30e9\u30b9\u30c8\u3002\" class=\"wp-image-7893\" srcset=\"https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/water-flosser-home-travel-formats.webp 1536w, https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/water-flosser-home-travel-formats-300x200.webp 300w, https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/water-flosser-home-travel-formats-1024x683.webp 1024w, https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/water-flosser-home-travel-formats-768x512.webp 768w, https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/water-flosser-home-travel-formats-18x12.webp 18w\" sizes=\"(max-width: 1536px) 100vw, 1536px\" \/><\/figure>\n\n<p>\u3053\u306e\u5206\u985e\u306f\u3001\u9069\u7528\u3055\u308c\u308b\u898f\u5236\u3092\u691c\u8a0e\u3059\u308b\u969b\u306e\u51fa\u767a\u70b9\u3067\u3059\u3002\u30dd\u30f3\u30d7\u3068\u30ce\u30ba\u30eb\u3092\u5099\u3048\u305f\u88fd\u54c1\u304c\u3001\u3059\u3079\u3066\u540c\u3058\u6271\u3044\u306b\u306a\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u5fc5\u8981\u306a\u624b\u7d9a\u304d\u3092\u5224\u65ad\u3059\u308b\u524d\u306b\u3001\u6b21\u306e\u70b9\u3092\u6587\u66f8\u5316\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n<ul>\n<li>\u88fd\u54c1\u304c\u610f\u56f3\u3059\u308b\u6a5f\u80fd<\/li>\n<li>\u8ab0\u304c\u4f7f\u7528\u3057\u3001\u3069\u3053\u3067\u8ca9\u58f2\u3059\u308b\u304b<\/li>\n<li>\u30e9\u30d9\u30eb\u3001\u5305\u88c5\u3001\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u306b\u8a18\u8f09\u3059\u308b\u8a34\u6c42\u5185\u5bb9<\/li>\n<li>\u6a19\u6e96\u7684\u306a\u53e3\u8154\u6d17\u6d44\u5668\u304b\u3001\u8ffd\u52a0\u306e\u533b\u7642\u76ee\u7684\u3092\u6301\u3064\u88fd\u54c1\u304b<\/li>\n<li>\u7c73\u56fd\u5411\u3051\u88fd\u54c1\u306e\u88fd\u9020\u3001\u8f38\u5165\u3001\u6d41\u901a\u3092\u62c5\u3046\u4e8b\u696d\u8005<\/li>\n<\/ul>\n\n<p class=\"translation-block\"><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpcd\/classification.cfm?id=EFS\" target=\"_blank\" rel=\"noopener\">FDA\u306eEFS\u5206\u985e\u60c5\u5831<\/a>\u3092\u3001\u5bfe\u8c61\u88fd\u54c1\u306b\u9069\u7528\u3055\u308c\u308b\u8981\u4ef6\u3068\u4f75\u305b\u3066\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u5206\u985e\u30b3\u30fc\u30c9\u306f\u5224\u65ad\u306e\u53c2\u8003\u306b\u306a\u308a\u307e\u3059\u304c\u3001\u3059\u3079\u3066\u306e\u30e2\u30c7\u30eb\u306b\u5bfe\u3059\u308b\u5305\u62ec\u7684\u306a\u627f\u8a8d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n\n<h2>FDA\u767b\u9332\u306fFDA\u627f\u8a8d\u3067\u306f\u3042\u308a\u307e\u305b\u3093<\/h2>\n\n<p>\u65bd\u8a2d\u767b\u9332\u3001\u6a5f\u5668\u30ea\u30b9\u30c6\u30a3\u30f3\u30b0\uff08\u88fd\u54c1\u60c5\u5831\u306e\u5c4a\u51fa\uff09\u3001\u5e02\u8ca9\u524d\u5be9\u67fb\u306f\u3001\u305d\u308c\u305e\u308c\u7570\u306a\u308b\u624b\u7d9a\u304d\u3067\u3059\u3002<\/p>\n\n<!-- Preserved existing figure: media 3975 -->\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1536\" height=\"1024\" src=\"https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/water-flosser-reservoir-seal-inspection.webp\" alt=\"\u6280\u8853\u8005\u304c\u4f5c\u696d\u53f0\u3067\u53e3\u8154\u6d17\u6d44\u5668\u306e\u6c34\u30bf\u30f3\u30af\u306e\u63a5\u7d9a\u90e8\u3068\u30b7\u30fc\u30eb\u3092\u70b9\u691c\u3059\u308b\u30a4\u30e9\u30b9\u30c8\u3002\" class=\"wp-image-7894\" srcset=\"https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/water-flosser-reservoir-seal-inspection.webp 1536w, https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/water-flosser-reservoir-seal-inspection-300x200.webp 300w, https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/water-flosser-reservoir-seal-inspection-1024x683.webp 1024w, https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/water-flosser-reservoir-seal-inspection-768x512.webp 768w, https:\/\/relish-tech.com\/wp-content\/uploads\/2026\/09\/water-flosser-reservoir-seal-inspection-18x12.webp 18w\" sizes=\"(max-width: 1536px) 100vw, 1536px\" \/><\/figure>\n\n<p>\u65bd\u8a2d\u304c\u767b\u9332\u3055\u308c\u3001\u6a5f\u5668\u304cFDA\u306e\u30b7\u30b9\u30c6\u30e0\u306b\u63b2\u8f09\u3055\u308c\u3066\u3044\u3066\u3082\u3001FDA\u306e\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\uff08\u5e02\u8ca9\u8a31\u53ef\uff09\u3084\u627f\u8a8d\u3092\u5f97\u305f\u3053\u3068\u306b\u306f\u306a\u308a\u307e\u305b\u3093\u3002FDA\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u3064\u3044\u3066\u4e00\u822c\u7684\u306a\u300cFDA\u767b\u9332\u8a3c\u660e\u66f8\u300d\u3092\u767a\u884c\u3057\u3066\u3044\u306a\u3044\u3068\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u3002\u767b\u9332\u8a18\u9332\u3060\u3051\u3067\u306f\u3001FDA\u304c\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3084\u6027\u80fd\u3092\u5be9\u67fb\u3057\u305f\u3053\u3068\u3082\u8a3c\u660e\u3055\u308c\u307e\u305b\u3093\u3002<\/p>\n\n<p>\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u767a\u884c\u307e\u305f\u306f\u7b2c\u4e09\u8005\u767a\u884c\u306e\u767b\u9332\u8a3c\u660e\u66f8\u306f\u3001FDA\u306e\u627f\u8a8d\u3092\u610f\u5473\u3057\u307e\u305b\u3093\u3002\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u66f8\u985e\u3092\u78ba\u8a8d\u3059\u308b\u969b\u306f\u3001\u6b21\u306e\u8868\u73fe\u3092\u533a\u5225\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n<ul>\n<li>\u300c\u88fd\u54c1\u306fFDA\u88fd\u54c1\u30b3\u30fc\u30c9EFS\u306b\u57fa\u3065\u304d\u8a55\u4fa1\u4e2d\u300d\u306f\u3001\u898f\u5236\u8a08\u753b\u4e0a\u306e\u624b\u9806\u3092\u793a\u3057\u307e\u3059\u3002<\/li>\n<li>\u300c\u65bd\u8a2d\u304c\u767b\u9332\u3055\u308c\u3001\u6a5f\u5668\u304c\u30ea\u30b9\u30c8\u306b\u63b2\u8f09\u300d\u306f\u3001\u8a18\u9332\u306e\u5b58\u5728\u3092\u793a\u3059\u3082\u306e\u3067\u3001\u627f\u8a8d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/li>\n<li>\u300cFDA cleared\uff08\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u53d6\u5f97\u6e08\u307f\uff09\u300d\u307e\u305f\u306f\u300cFDA approved\uff08\u627f\u8a8d\u6e08\u307f\uff09\u300d\u3068\u3044\u3046\u8868\u73fe\u306f\u3001\u5bfe\u8c61\u88fd\u54c1\u3068\u9069\u7528\u3055\u308c\u308b\u624b\u7d9a\u304d\u304c\u3001\u305d\u306e\u8a18\u8f09\u3092\u88cf\u4ed8\u3051\u308b\u5834\u5408\u306b\u9650\u3063\u3066\u4f7f\u7528\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/li>\n<\/ul>\n\n<p class=\"translation-block\"><p>\u88fd\u54c1\u30da\u30fc\u30b8\u3084\u55b6\u696d\u8cc7\u6599\u3067\u767b\u9332\u306b\u95a2\u3059\u308b\u8868\u73fe\u3092\u4f7f\u7528\u3059\u308b\u524d\u306b\u3001<a href=\"https:\/\/www.fda.gov\/medical-devices\/consumers-medical-devices\/are-there-fda-registered-or-fda-certified-medical-devices-how-do-i-know-what-fda-approved\" target=\"_blank\" rel=\"noopener\">\u767b\u9332\u6e08\u307f\u30fb\u8a8d\u8a3c\u6e08\u307f\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308bFDA\u306e\u8aac\u660e<\/a>\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p><\/p>\n\n<h2>\u767b\u9332\u3068\u30ea\u30b9\u30c6\u30a3\u30f3\u30b0\u3092\u8ab0\u304c\u62c5\u5f53\u3057\u307e\u3059\u304b\uff1f<\/h2>\n\n<p>FDA\u306f21 CFR Part 807\u306b\u57fa\u3065\u304d\u3001\u65bd\u8a2d\u767b\u9332\u3068\u6a5f\u5668\u30ea\u30b9\u30c6\u30a3\u30f3\u30b0\u306e\u8981\u4ef6\u3092\u5b9a\u3081\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/www.fda.gov\/medical-devices\/device-registration-and-listing\/who-must-register-list-and-pay-fee\" target=\"_blank\" rel=\"noopener\">\u4e8b\u696d\u6d3b\u52d5\u5225\u306e\u8981\u4ef6\u8868<\/a> \u3067\u306f\u3001\u88fd\u9020\u696d\u8005\u3001\u53d7\u8a17\u88fd\u9020\u696d\u8005\u3001\u521d\u56de\u8f38\u5165\u696d\u8005\uff08initial importer\uff09\u3001\u8ca9\u58f2\u696d\u8005\u304c\u533a\u5225\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u3001\u6d77\u5916\u306e\u5b8c\u6210\u54c1\u88fd\u9020\u696d\u8005\u306f\u901a\u5e38\u3001\u767b\u9332\u3068\u30ea\u30b9\u30c6\u30a3\u30f3\u30b0\u3092\u884c\u3044\u307e\u3059\u3002\u4e00\u65b9\u3001\u521d\u56de\u8f38\u5165\u696d\u8005\u306f\u767b\u9332\u3092\u884c\u3044\u3001\u88fd\u9020\u696d\u8005\u306e\u60c5\u5831\u3092\u5c4a\u3051\u51fa\u307e\u3059\u304c\u3001\u6a5f\u5668\u81ea\u4f53\u306e\u30ea\u30b9\u30c6\u30a3\u30f3\u30b0\u306f\u884c\u3044\u307e\u305b\u3093\u3002\u8f38\u5165\u3092\u884c\u308f\u306a\u3044\u7c73\u56fd\u5185\u306e\u8ca9\u58f2\u696d\u8005\u306b\u306f\u3001\u5225\u306e\u5f79\u5272\u304c\u9069\u7528\u3055\u308c\u307e\u3059\u3002<\/p>\n\n<p>\u51fa\u8377\u524d\u306b\u5f79\u5272\u5206\u62c5\u3092\u5408\u610f\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u5305\u88c5\u306b\u8a18\u8f09\u3055\u308c\u305f\u30d6\u30e9\u30f3\u30c9\u540d\u3060\u3051\u3067\u306f\u3001\u5404\u4e8b\u696d\u8005\u304c\u3069\u306e\u898f\u5236\u4e0a\u306e\u5f79\u5272\u3092\u62c5\u3046\u304b\u306f\u5224\u65ad\u3067\u304d\u307e\u305b\u3093\u3002<\/p>\n\n<h2>\u3059\u3079\u3066\u306e\u53e3\u8154\u6d17\u6d44\u5668\u306b510(k)\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/h2>\n\n<p>\u5fc5\u305a\u3057\u3082\u5fc5\u8981\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002EFS\u5206\u985e\u306f\u901a\u5e38510(k)\u514d\u9664\u3067\u3059\u304c\u3001\u514d\u9664\u306b\u306f\u5236\u9650\u304c\u3042\u308a\u307e\u3059\u3002\u65b0\u30e2\u30c7\u30eb\u3001\u7570\u306a\u308b\u4f7f\u7528\u76ee\u7684\u3001\u6cbb\u7642\u3092\u3046\u305f\u3046\u8868\u793a\u3001\u91cd\u8981\u306a\u8a2d\u8a08\u5909\u66f4\u306f\u5224\u65ad\u306b\u5f71\u97ff\u3059\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n<p>\u7c73\u56fd\u3067\u767a\u58f2\u3059\u308b\u524d\u306b\u3001\u6b21\u306e\u70b9\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n<ol>\n<li>\u88fd\u54c1\u306f\u53e3\u8154\u6d17\u6d44\u5668\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u8a72\u5f53\u3057\u307e\u3059\u304b\uff1f<\/li>\n<li>\u4f7f\u7528\u76ee\u7684\u306f\u305d\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u3068\u4e00\u81f4\u3057\u3066\u3044\u307e\u3059\u304b\uff1f<\/li>\n<li>\u8a34\u6c42\u5185\u5bb9\u306f\u3001\u88fd\u54c1\u306b\u9069\u7528\u53ef\u80fd\u306a\u6839\u62e0\u3068\u898f\u5236\u7d4c\u8def\u306e\u7bc4\u56f2\u5185\u3067\u3059\u304b\uff1f<\/li>\n<li>\u88fd\u9020\u696d\u8005\u3001\u8f38\u5165\u696d\u8005\u3001\u8ca9\u58f2\u696d\u8005\u306f\u3001\u305d\u308c\u305e\u308c\u306e\u5f79\u5272\u306b\u5fc5\u8981\u306a\u8cac\u4efb\u3092\u62c5\u3063\u3066\u3044\u307e\u3059\u304b\uff1f<\/li>\n<li>\u8868\u793a\u3001\u96fb\u6c17\u5b89\u5168\u3001\u751f\u4f53\u9069\u5408\u6027\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3001\u6027\u80fd\u306b\u95a2\u3059\u308b\u8cc7\u6599\u306f\u3001\u5bfe\u8c61\u30e2\u30c7\u30eb\u3068\u5e02\u5834\u306b\u9069\u3057\u3066\u3044\u307e\u3059\u304b\uff1f<\/li>\n<\/ol>\n\n<p>\u5b8c\u6210\u54c1\u306b\u9069\u7528\u3055\u308c\u308b\u624b\u7d9a\u304d\u306f\u3001\u62c5\u5f53\u306e\u898f\u5236\u5c02\u9580\u5bb6\u307e\u305f\u306f\u7c73\u56fd\u306e\u8f38\u5165\u696d\u8005\u306b\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u672c\u8a18\u4e8b\u306f\u8a08\u753b\u6642\u306e\u53c2\u8003\u60c5\u5831\u3067\u3042\u308a\u3001\u500b\u5225\u88fd\u54c1\u306e\u898f\u5236\u8a55\u4fa1\u306b\u4ee3\u308f\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n\n<h2>\u7c73\u56fd\u767a\u58f2\u524d\u306bOEM\u8abf\u9054\u62c5\u5f53\u8005\u304c\u78ba\u8a8d\u3059\u3079\u304d\u3053\u3068<\/h2>\n\n<p>\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306b\u306f\u3001\u78ba\u8a8d\u53ef\u80fd\u306a\u5f62\u3067\u88fd\u54c1\u5185\u5bb9\u3092\u8aac\u660e\u3057\u3066\u3082\u3089\u3044\u307e\u3057\u3087\u3046\u3002<\/p>\n\n<ul>\n<li><strong>\u4f7f\u7528\u76ee\u7684\uff1a<\/strong> \u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u6a5f\u5668\u304c\u4f55\u3092\u76ee\u7684\u306b\u8a2d\u8a08\u3055\u308c\u305f\u3068\u8aac\u660e\u3057\u3066\u3044\u307e\u3059\u304b\uff1f<\/li>\n<li><strong>\u5bfe\u8c61\u30e2\u30c7\u30eb\uff1a<\/strong> \u3069\u306e\u578b\u756a\u3001\u30ce\u30ba\u30eb\u30bb\u30c3\u30c8\u3001\u30d0\u30c3\u30c6\u30ea\u30fc\u69cb\u6210\u3001\u4ed8\u5c5e\u54c1\u304c\u5bfe\u8c61\u3067\u3059\u304b\uff1f<\/li>\n<li><strong>\u6839\u62e0\u8cc7\u6599\uff1a<\/strong> \u9632\u6c34\u6027\u3001\u96fb\u6c17\u5b89\u5168\u3001\u6750\u6599\u3001\u6027\u80fd\u3092\u88cf\u4ed8\u3051\u308b\u8a66\u9a13\u306f\u4f55\u3067\u3059\u304b\uff1f<\/li>\n<li><strong>\u8868\u793a\uff1a<\/strong> \u4f7f\u7528\u76ee\u7684\u3001\u8b66\u544a\u3001\u53d6\u6271\u8aac\u660e\u3001\u8f38\u5165\u696d\u8005\u60c5\u5831\u306f\u3001\u5305\u88c5\u3068\u30aa\u30f3\u30e9\u30a4\u30f3\u63b2\u8f09\u3067\u4e00\u81f4\u3057\u3066\u3044\u307e\u3059\u304b\uff1f<\/li>\n<li><strong>\u898f\u5236\u4e0a\u306e\u5f79\u5272\uff1a<\/strong> \u8ab0\u304c\u88fd\u9020\u696d\u8005\u3068\u3057\u3066\u8a18\u9332\u3055\u308c\u3001\u8ab0\u304c\u8f38\u5165\u3057\u3001\u8ab0\u304c\u95a2\u9023\u8a18\u9332\u3092\u4fdd\u7ba1\u3057\u307e\u3059\u304b\uff1f<\/li>\n<li><strong>\u8a34\u6c42\u5185\u5bb9\u306e\u7ba1\u7406\uff1a<\/strong> \u3069\u306e\u8868\u73fe\u304c\u88fd\u54c1\u7279\u9577\u3067\u3001\u3069\u308c\u304c\u533b\u7642\u307e\u305f\u306f\u81e8\u5e8a\u4e0a\u306e\u8a34\u6c42\u306b\u5f53\u305f\u308a\u307e\u3059\u304b\uff1f<\/li>\n<\/ul>\n\n<p>\u56de\u7b54\u306f\u8ca9\u58f2\u4e88\u5b9a\u306e\u30e2\u30c7\u30eb\u306b\u7d10\u3065\u3051\u3066\u304f\u3060\u3055\u3044\u3002\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306e\u4e00\u822c\u7684\u306a\u300cFDA\u6e96\u62e0\u300d\u3068\u3044\u3046\u8aac\u660e\u304c\u3001\u65b0\u3057\u3044\u7b50\u4f53\u3001\u30dd\u30f3\u30d7\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u6a5f\u80fd\u3001\u7570\u306a\u308b\u8a34\u6c42\u5185\u5bb9\u307e\u3067\u81ea\u52d5\u7684\u306b\u5bfe\u8c61\u3068\u3059\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n\n<h2>FDA\u898f\u5247\u306f\u5e02\u5834\u53c2\u5165\u8981\u4ef6\u306e\u4e00\u90e8\u3067\u3059<\/h2>\n\n<p>\u7c73\u56fd\u306f\u4e00\u3064\u306e\u5e02\u5834\u3067\u3059\u3002\u540c\u3058\u53e3\u8154\u6d17\u6d44\u5668\u3092\u6b27\u5dde\u3001\u82f1\u56fd\u3001\u305d\u306e\u4ed6\u306e\u5730\u57df\u3067\u8ca9\u58f2\u3059\u308b\u5834\u5408\u306f\u3001\u8ca9\u58f2\u5148\u3054\u3068\u306b\u5225\u306e\u9069\u5408\u6027\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3092\u4f5c\u6210\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u88fd\u54c1\u540d\u3001\u4f7f\u7528\u76ee\u7684\u3001\u96fb\u6c17\u8981\u4ef6\u3001\u8868\u793a\u3001\u9069\u5408\u6027\u8cc7\u6599\u306f\u5e02\u5834\u306b\u3088\u3063\u3066\u7570\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n<p>\u7c73\u56fd\u306eEFS\u5206\u985e\u3092\u300cFDA\u627f\u8a8d\u6e08\u307f\u3067\u4e16\u754c\u4e2d\u306e\u533b\u7642\u8a8d\u8a3c\u3092\u53d6\u5f97\u300d\u3068\u3044\u3063\u305f\u4e16\u754c\u5171\u901a\u306e\u8868\u73fe\u306b\u7f6e\u304d\u63db\u3048\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002\u7c73\u56fd\u306e\u898f\u5236\u8aac\u660e\u306f\u7c73\u56fd\u306e\u6839\u62e0\u8cc7\u6599\u306b\u6cbf\u3063\u3066\u8a18\u8f09\u3057\u3001\u4ed6\u5e02\u5834\u306f\u305d\u308c\u305e\u308c\u306e\u898f\u5247\u306b\u57fa\u3065\u3044\u3066\u8a55\u4fa1\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n<h2>\u53e3\u8154\u6d17\u6d44\u5668\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3067Relish Tech\u304c\u652f\u63f4\u3067\u304d\u308b\u3053\u3068<\/h2>\n\n<p>Relish Tech\u306f\u53e3\u8154\u30b1\u30a2\u88fd\u54c1\u306eOEM\/ODM\u3092\u652f\u63f4\u3057\u3001\u88fd\u54c1\u8a2d\u8a08\u3001\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u3001\u8a66\u4f5c\u3001\u91d1\u578b\u3001\u7d44\u7acb\u3001\u5305\u88c5\u3001\u30e2\u30c7\u30eb\u5225\u8a66\u9a13\u306e\u8abf\u6574\u306b\u5bfe\u5fdc\u3057\u307e\u3059\u3002 <a href=\"https:\/\/relish-tech.com\/jp\/%e8%aa%8d%e8%a8%bc\/\">\u8a8d\u8a3c\u30fb\u54c1\u8cea\u30da\u30fc\u30b8<\/a> \u306f\u3001\u540c\u793e\u306e\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u3068\u5229\u7528\u53ef\u80fd\u306a\u9069\u5408\u6027\u652f\u63f4\u3092\u78ba\u8a8d\u3059\u308b\u969b\u306e\u51fa\u767a\u70b9\u3068\u3057\u3066\u5229\u7528\u3067\u304d\u307e\u3059\u3002<\/p>\n\n<p>\u53e3\u8154\u6d17\u6d44\u5668\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3067\u306f\u3001\u307e\u305a\u30e2\u30c7\u30eb\u3068\u5bfe\u8c61\u5e02\u5834\u3092\u660e\u78ba\u306b\u3057\u307e\u3059\u3002\u305d\u306e\u4e0a\u3067Relish\u306f\u3001\u9069\u7528\u3055\u308c\u308b\u624b\u7d9a\u304d\u306b\u5fc5\u8981\u306a\u30dd\u30f3\u30d7\u3001\u6c34\u30bf\u30f3\u30af\u3001\u30d0\u30c3\u30c6\u30ea\u30fc\u3001\u30ce\u30ba\u30eb\u30bb\u30c3\u30c8\u3001\u5145\u96fb\u65b9\u5f0f\u3001\u7b50\u4f53\u3001\u5305\u88c5\u3001\u8cc7\u6599\u306b\u3064\u3044\u3066\u3001\u30d6\u30e9\u30f3\u30c9\u62c5\u5f53\u8005\u3068\u691c\u8a0e\u3067\u304d\u307e\u3059\u3002\u898f\u5236\u95a2\u9023\u306e\u652f\u63f4\u306f\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u9032\u3081\u308b\u305f\u3081\u306e\u652f\u63f4\u3067\u3042\u308a\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c\u88fd\u9020\u3059\u308b\u3059\u3079\u3066\u306e\u88fd\u54c1\u304cFDA\u627f\u8a8d\u6e08\u307f\u3068\u3044\u3046\u610f\u5473\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n\n<p class=\"translation-block\">\u88fd\u54c1\u306b\u3064\u3044\u3066\u306f\u3001<a href=\"https:\/\/relish-tech.com\/jp\/%e3%82%a6%e3%82%a9%e3%83%bc%e3%82%bf%e3%83%bc%e3%83%95%e3%83%ad%e3%83%83%e3%82%b5%e3%83%bc-oem-odm%e3%83%90%e3%82%a4%e3%83%a4%e3%83%bc%e3%82%ac%e3%82%a4%e3%83%89\/\" target=\"_self\">\u53e3\u8154\u6d17\u6d44\u5668OEM\/ODM\u8abf\u9054\u30ac\u30a4\u30c9<\/a>\u3092\u3054\u89a7\u3044\u305f\u3060\u304f\u304b\u3001<a href=\"https:\/\/relish-tech.com\/jp\/%e3%82%b3%e3%83%b3%e3%82%bf%e3%82%af%e3%83%88\/\" target=\"_self\">Relish Tech<\/a>\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/p>\n\n<p>\u30e2\u30c7\u30eb\u3001\u69cb\u6210\u3001\u6ce8\u6587\u8981\u4ef6\u306b\u57fa\u3065\u304f\u5de5\u5834\u76f4\u8ca9\u4fa1\u683c\u306b\u3064\u3044\u3066\u306f\u3001Relish Tech\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/p>\n\n<h2>\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n\n<h3>\u7c73\u56fd\u3067\u306f\u53e3\u8154\u6d17\u6d44\u5668\u306f\u533b\u7642\u6a5f\u5668\u3067\u3059\u304b\uff1f<\/h3>\n\n<p>FDA\u306f\u53e3\u8154\u6d17\u6d44\u5668\u3092\u88fd\u54c1\u30b3\u30fc\u30c9EFS\u306e\u30af\u30e9\u30b9I\u533b\u7642\u6a5f\u5668\u30ab\u30c6\u30b4\u30ea\u30fc\u3068\u3057\u3066\u63b2\u8f09\u3057\u3066\u3044\u307e\u3059\u3002\u500b\u5225\u30e2\u30c7\u30eb\u304c\u8a72\u5f53\u3059\u308b\u304b\u306f\u3001\u4f7f\u7528\u76ee\u7684\u3001\u8a34\u6c42\u5185\u5bb9\u3001\u8a2d\u8a08\u306b\u3088\u3063\u3066\u6c7a\u307e\u308a\u307e\u3059\u3002<\/p>\n\n<h3>FDA\u767b\u9332\u304c\u3042\u308c\u3070\u3001\u53e3\u8154\u6d17\u6d44\u5668\u306fFDA\u627f\u8a8d\u6e08\u307f\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u304b\uff1f<\/h3>\n\n<p>\u3044\u3044\u3048\u3002\u65bd\u8a2d\u767b\u9332\u3068\u6a5f\u5668\u30ea\u30b9\u30c6\u30a3\u30f3\u30b0\u306f\u3001FDA\u306e\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\uff08\u5e02\u8ca9\u8a31\u53ef\uff09\u3084\u627f\u8a8d\u3068\u306f\u7570\u306a\u308a\u307e\u3059\u3002FDA\u306f\u533b\u7642\u6a5f\u5668\u306b\u3064\u3044\u3066\u4e00\u822c\u7684\u306a\u767b\u9332\u8a3c\u660e\u66f8\u3092\u767a\u884c\u3057\u3066\u3044\u307e\u305b\u3093\u3002<\/p>\n\n<h3>\u3059\u3079\u3066\u306e\u53e3\u8154\u6d17\u6d44\u5668\u306b510(k)\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/h3>\n\n<p>\u3044\u3044\u3048\u3002EFS\u30ab\u30c6\u30b4\u30ea\u30fc\u306f\u901a\u5e38510(k)\u5e02\u8ca9\u524d\u5c4a\u51fa\u304c\u514d\u9664\u3055\u308c\u307e\u3059\u304c\u3001\u9069\u7528\u3055\u308c\u308b\u5236\u9650\u304c\u3042\u308a\u307e\u3059\u3002\u6b63\u78ba\u306a\u30e2\u30c7\u30eb\u3068\u4f7f\u7528\u76ee\u7684\u306b\u3064\u3044\u3066\u898f\u5236\u7d4c\u8def\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n<h3>OEM\u8abf\u9054\u62c5\u5f53\u8005\u306f\u6700\u521d\u306b\u4f55\u3092\u78ba\u8a8d\u3059\u3079\u304d\u3067\u3059\u304b\uff1f<\/h3>\n\n<p>\u4f7f\u7528\u76ee\u7684\u3001\u30e2\u30c7\u30eb\u69cb\u6210\u3001\u8a34\u6c42\u5185\u5bb9\u3001\u8cac\u4efb\u3092\u62c5\u3046\u88fd\u9020\u696d\u8005\u3068\u8f38\u5165\u696d\u8005\u3001\u8868\u793a\u3001\u8a66\u9a13\u8cc7\u6599\u3001\u5bfe\u8c61\u5e02\u5834\u306e\u898f\u5236\u7d4c\u8def\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n<h3>\u53e3\u8154\u6d17\u6d44\u5668\u306eOEM\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3067\u306f\u3001\u6700\u4f4e\u767a\u6ce8\u6570\u91cf\uff08MOQ\uff09\u3092\u4f55\u53f0\u3068\u898b\u8fbc\u3080\u3079\u304d\u3067\u3059\u304b\uff1f<\/h3>\n\n<p>Relish Tech\u306e\u6a19\u6e96MOQ\u306f <strong>1,000\u53f0<\/strong>\u3067\u3059\u3002\u69cb\u6210\u3084\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u8981\u4ef6\u306b\u3064\u3044\u3066\u3001\u5f53\u793e\u30c1\u30fc\u30e0\u306b\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044\u3002<\/p>\n\n<h2>\u53c2\u8003\u8cc7\u6599<\/h2>\n\n<ul>\n<li><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpcd\/classification.cfm?id=EFS\" target=\"_blank\" rel=\"noopener\">FDA\u88fd\u54c1\u30b3\u30fc\u30c9EFS\uff1a\u53e3\u8154\u6d17\u6d44\u5668<\/a><\/li>\n<li><a href=\"https:\/\/www.fda.gov\/medical-devices\/consumers-medical-devices\/are-there-fda-registered-or-fda-certified-medical-devices-how-do-i-know-what-fda-approved\" target=\"_blank\" rel=\"noopener\">FDA\uff1aFDA\u767b\u9332\u307e\u305f\u306fFDA\u8a8d\u8a3c\u3092\u53d7\u3051\u305f\u533b\u7642\u6a5f\u5668\u306f\u5b58\u5728\u3059\u308b\uff1f<\/a><\/li>\n<li><a href=\"https:\/\/relish-tech.com\/jp\/%e8%aa%8d%e8%a8%bc\/\">Relish Tech\u306e\u8a8d\u8a3c\u30fb\u54c1\u8cea\u60c5\u5831<\/a><\/li>\n<li><a href=\"https:\/\/relish-tech.com\/jp\/%e3%82%a6%e3%82%a9%e3%83%bc%e3%82%bf%e3%83%bc%e3%83%95%e3%83%ad%e3%83%83%e3%82%b5%e3%83%bc-oem-odm%e3%83%90%e3%82%a4%e3%83%a4%e3%83%bc%e3%82%ac%e3%82%a4%e3%83%89\/\">Relish Tech\u306e\u53e3\u8154\u6d17\u6d44\u5668OEM\/ODM\u8abf\u9054\u30ac\u30a4\u30c9<\/a><\/li>\n<\/ul>\n<\/article>","protected":false},"excerpt":{"rendered":"<p>In the U.S., FDA lists oral irrigation units under product code EFS as Class I medical devices. A water flosser\u2019s [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":8527,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[71],"tags":[],"class_list":["post-3973","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-quality-compliance"],"_links":{"self":[{"href":"https:\/\/relish-tech.com\/jp\/wp-json\/wp\/v2\/posts\/3973","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/relish-tech.com\/jp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/relish-tech.com\/jp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/relish-tech.com\/jp\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/relish-tech.com\/jp\/wp-json\/wp\/v2\/comments?post=3973"}],"version-history":[{"count":5,"href":"https:\/\/relish-tech.com\/jp\/wp-json\/wp\/v2\/posts\/3973\/revisions"}],"predecessor-version":[{"id":8413,"href":"https:\/\/relish-tech.com\/jp\/wp-json\/wp\/v2\/posts\/3973\/revisions\/8413"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/relish-tech.com\/jp\/wp-json\/wp\/v2\/media\/8527"}],"wp:attachment":[{"href":"https:\/\/relish-tech.com\/jp\/wp-json\/wp\/v2\/media?parent=3973"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/relish-tech.com\/jp\/wp-json\/wp\/v2\/categories?post=3973"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/relish-tech.com\/jp\/wp-json\/wp\/v2\/tags?post=3973"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}