{"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":"%e6%b0%b4%e7%89%99%e7%ba%bf%e6%98%af%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e5%90%97","status":"publish","type":"post","link":"https:\/\/relish-tech.com\/cn\/is-the-water-flosser-a-medical-device\/","title":{"rendered":"\u51b2\u7259\u5668\u5c5e\u4e8e\u533b\u7597\u5668\u68b0\u5417\uff1f\u7f8e\u56fd\u5e02\u573a\u51c6\u5165\u4e2d\u7684 FDA \u89c4\u5219"},"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>\u5728\u7f8e\u56fd\uff0cFDA \u5c06\u53e3\u8154\u51b2\u6d17\u5668\u5217\u5165 EFS \u4ea7\u54c1\u4ee3\u7801\uff0c\u5f52\u4e3a I \u7c7b\u533b\u7597\u5668\u68b0\u3002\u51b2\u7259\u5668\u662f\u5426\u7b26\u5408\u8fd9\u4e00\u7c7b\u522b\uff0c\u53d6\u51b3\u4e8e\u5176\u9884\u671f\u7528\u9014\u3001\u8bbe\u8ba1\u548c\u5ba3\u79f0\u3002\u5982\u9700\u529e\u7406\u6ce8\u518c\uff0c\u6ce8\u518c\u4e5f\u4e0d\u7b49\u4e8e FDA \u6279\u51c6\u3002<\/p>\n\n<h2>FDA \u5206\u7c7b\u4fe1\u606f\u8bf4\u660e\u4e86\u4ec0\u4e48<\/h2>\n\n<p>\u51b2\u7259\u5668\u5c06\u6c34\u6d41\u5bfc\u5411\u7259\u7f1d\u548c\u7259\u9f88\u7ebf\u9644\u8fd1\u3002\u6cd5\u89c4\u5206\u7c7b\u5173\u6ce8\u7684\u662f\u6210\u54c1\u53ca\u5176\u9884\u671f\u7528\u9014\uff0c\u800c\u4e0d\u53ea\u662f\u6e05\u6d01\u539f\u7406\u3002<\/p>\n\n<p>FDA \u5728\u533b\u7597\u5668\u68b0\u5206\u7c7b\u6570\u636e\u5e93\u4e2d\u5c06\u53e3\u8154\u51b2\u6d17\u5668\u5217\u5165 EFS \u4ea7\u54c1\u4ee3\u7801\u3002\u8be5\u6761\u76ee\u5c06\u5176\u5217\u4e3a I \u7c7b\u5668\u68b0\u7c7b\u522b\uff0c\u5e76\u901a\u5e38\u8c41\u514d 510(k) \u4e0a\u5e02\u524d\u901a\u77e5\uff0c\u4f46\u4ecd\u987b\u9075\u5b88\u9002\u7528\u4e8e\u8be5\u5668\u68b0\u53ca\u5176\u9884\u671f\u7528\u9014\u7684\u8c41\u514d\u9650\u5236\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\u4e2d\u53f0\u5f0f\u51b2\u7259\u5668\u4e0e\u65c5\u884c\u6536\u7eb3\u888b\u65c1\u4fbf\u643a\u5f0f\u51b2\u7259\u5668\u7684\u793a\u610f\u56fe.\" 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>\u8fd9\u4e00\u5206\u7c7b\u53ef\u4f5c\u4e3a\u6cd5\u89c4\u89c4\u5212\u7684\u8d77\u70b9\u3002\u4e0d\u80fd\u56e0\u6b64\u5c06\u6240\u6709\u5e26\u6709\u6c34\u6cf5\u548c\u55b7\u5634\u7684\u4ea7\u54c1\u90fd\u89c6\u4e3a\u76f8\u540c\u7684\u6cd5\u89c4\u7c7b\u522b\u3002\u9009\u62e9\u5408\u89c4\u8def\u5f84\u524d\uff0c\u5e94\u8bb0\u5f55\uff1a<\/p>\n\n<ul>\n<li>\u4ea7\u54c1\u7684\u9884\u671f\u7528\u9014\uff1b<\/li>\n<li>\u4f7f\u7528\u8005\u53ca\u9500\u552e\u5e02\u573a\uff1b<\/li>\n<li>\u6807\u7b7e\u3001\u5305\u88c5\u548c\u7f51\u7ad9\u4e0a\u5c06\u51fa\u73b0\u7684\u5ba3\u79f0\uff1b<\/li>\n<li>\u4ea7\u54c1\u662f\u5e38\u89c4\u53e3\u8154\u51b2\u6d17\u5668\uff0c\u8fd8\u662f\u53e6\u6709\u533b\u7597\u7528\u9014\uff1b<\/li>\n<li>\u8d1f\u8d23\u5728\u7f8e\u56fd\u5236\u9020\u3001\u8fdb\u53e3\u548c\u5206\u9500\u4ea7\u54c1\u7684\u516c\u53f8\u3002<\/li>\n<\/ul>\n\n<p class=\"translation-block\">\u8bf7\u5c06<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpcd\/classification.cfm?id=EFS\" target=\"_blank\" rel=\"noopener\">FDA \u7684 EFS \u5206\u7c7b\u4fe1\u606f<\/a>\u4e0e\u5177\u4f53\u4ea7\u54c1\u9002\u7528\u7684\u8981\u6c42\u7ed3\u5408\u8d77\u6765\u6838\u5bf9\u3002\u5206\u7c7b\u4ee3\u7801\u53ef\u4f5c\u4e3a\u5224\u65ad\u4f9d\u636e\uff0c\u4f46\u5e76\u4e0d\u4ee3\u8868\u6240\u6709\u578b\u53f7\u90fd\u5df2\u83b7\u5f97 FDA \u6279\u51c6\u3002<\/p>\n\n<h2>FDA \u6ce8\u518c\u4e0d\u7b49\u4e8e FDA \u6279\u51c6<\/h2>\n\n<p>\u673a\u6784\u6ce8\u518c\u3001\u5668\u68b0\u5217\u540d\u548c\u4e0a\u5e02\u524d\u5ba1\u67e5\u662f\u4e0d\u540c\u4e8b\u9879\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\u672f\u4eba\u5458\u5728\u5de5\u4f5c\u53f0\u4e0a\u68c0\u67e5\u51b2\u7259\u5668\u6c34\u7bb1\u8fde\u63a5\u4e0e\u5bc6\u5c01\u7684\u793a\u610f\u56fe.\" 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>\u4f01\u4e1a\u53ef\u80fd\u5df2\u5b8c\u6210\u6ce8\u518c\uff0c\u5668\u68b0\u4e5f\u53ef\u80fd\u5df2\u5217\u5165 FDA \u7cfb\u7edf\uff0c\u4f46 FDA \u5e76\u672a\u56e0\u6b64\u6279\u51c6\u6216\u8bb8\u53ef\u8be5\u4ea7\u54c1\u3002FDA \u8bf4\u660e\uff0c\u5b83\u4e0d\u4f1a\u4e3a\u533b\u7597\u5668\u68b0\u7b7e\u53d1\u901a\u7528\u7684\u201cFDA \u6ce8\u518c\u8bc1\u4e66\u201d\u3002\u6ce8\u518c\u8bb0\u5f55\u4e5f\u4e0d\u80fd\u8bc1\u660e FDA \u5df2\u5ba1\u67e5\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u6216\u6027\u80fd\u3002<\/p>\n\n<p>\u4f9b\u5e94\u5546\u6216\u7b2c\u4e09\u65b9\u51fa\u5177\u7684\u6ce8\u518c\u8bc1\u4e66\u4e0d\u7b49\u4e8e FDA \u6279\u51c6\u3002\u5ba1\u67e5\u4f9b\u5e94\u5546\u6587\u4ef6\u65f6\uff0c\u5e94\u533a\u5206\u4ee5\u4e0b\u8bf4\u6cd5\uff1a<\/p>\n\n<ul>\n<li>\u201c\u8be5\u4ea7\u54c1\u6b63\u5728\u6309 FDA EFS \u4ea7\u54c1\u4ee3\u7801\u8fdb\u884c\u8bc4\u4f30\u201d\u63cf\u8ff0\u7684\u662f\u6cd5\u89c4\u89c4\u5212\u6b65\u9aa4\u3002<\/li>\n<li>\u201c\u4f01\u4e1a\u5df2\u6ce8\u518c\u4e14\u5668\u68b0\u5df2\u5217\u540d\u201d\u63cf\u8ff0\u7684\u662f\u8bb0\u5f55\u72b6\u6001\uff0c\u5e76\u4e0d\u4ee3\u8868\u4ea7\u54c1\u83b7\u6279\u3002<\/li>\n<li>\u53ea\u6709\u5f53\u5177\u4f53\u4ea7\u54c1\u53ca\u9002\u7528\u8def\u5f84\u80fd\u591f\u652f\u6301\u65f6\uff0c\u624d\u53ef\u4f7f\u7528\u201cFDA \u5df2\u8bb8\u53ef\u201d\u6216\u201cFDA \u5df2\u6279\u51c6\u201d\u7684\u8bf4\u6cd5\u3002<\/li>\n<\/ul>\n\n<p class=\"translation-block\"><p>\u5728\u4ea7\u54c1\u9875\u9762\u6216\u9500\u552e\u6f14\u793a\u8d44\u6599\u4e2d\u4f7f\u7528\u201c\u6ce8\u518c\u201d\u76f8\u5173\u8868\u8ff0\u524d\uff0c\u8bf7\u5148\u9605\u8bfb<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 \u5173\u4e8e\u5df2\u6ce8\u518c\u53ca\u5df2\u8ba4\u8bc1\u533b\u7597\u5668\u68b0\u7684\u8bf4\u660e<\/a>\u3002<\/p><\/p>\n\n<h2>\u7531\u8c01\u8d1f\u8d23\u6ce8\u518c\u548c\u5217\u540d\uff1f<\/h2>\n\n<p>FDA \u6839\u636e\u300a\u7f8e\u56fd\u8054\u90a6\u6cd5\u89c4\u300b21 CFR Part 807 \u89c4\u5b9a\u4f01\u4e1a\u6ce8\u518c\u548c\u5668\u68b0\u5217\u540d\u8981\u6c42\u3002\u5176 <a href=\"https:\/\/www.fda.gov\/medical-devices\/device-registration-and-listing\/who-must-register-list-and-pay-fee\" target=\"_blank\" rel=\"noopener\">\u6309\u6d3b\u52a8\u5212\u5206\u7684\u5bf9\u7167\u8868<\/a> \u533a\u5206\u5236\u9020\u5546\u3001\u5408\u540c\u5236\u9020\u5546\u3001\u521d\u59cb\u8fdb\u53e3\u5546\u548c\u7ecf\u9500\u5546\u3002\u4f8b\u5982\uff0c\u5916\u56fd\u6210\u54c1\u5668\u68b0\u5236\u9020\u5546\u901a\u5e38\u9700\u8981\u6ce8\u518c\u5e76\u5217\u540d\uff1b\u521d\u59cb\u8fdb\u53e3\u5546\u9700\u8981\u6ce8\u518c\u5e76\u6ce8\u660e\u5236\u9020\u5546\uff0c\u800c\u4e0d\u662f\u81ea\u884c\u529e\u7406\u5668\u68b0\u5217\u540d\u3002\u672a\u4ece\u4e8b\u8fdb\u53e3\u7684\u7f8e\u56fd\u5883\u5185\u7ecf\u9500\u5546\u627f\u62c5\u4e0d\u540c\u804c\u8d23\u3002<\/p>\n\n<p>\u53d1\u8d27\u524d\u5e94\u660e\u786e\u8fd9\u4e9b\u804c\u8d23\u3002\u5305\u88c5\u4e0a\u7684\u54c1\u724c\u540d\u79f0\u672c\u8eab\u65e0\u6cd5\u8bf4\u660e\u5404\u5bb6\u4f01\u4e1a\u627f\u62c5\u54ea\u4e00\u79cd\u6cd5\u89c4\u89d2\u8272\u3002<\/p>\n\n<h2>\u6bcf\u6b3e\u51b2\u7259\u5668\u90fd\u9700\u8981 510(k) \u5417\uff1f<\/h2>\n\n<p>\u672a\u5fc5\u3002EFS \u5206\u7c7b\u901a\u5e38\u8c41\u514d 510(k) \u4e0a\u5e02\u524d\u901a\u77e5\uff0c\u4f46\u8be5\u8c41\u514d\u6709\u9002\u7528\u9650\u5236\u3002\u65b0\u578b\u53f7\u3001\u4e0d\u540c\u7684\u9884\u671f\u7528\u9014\u3001\u6cbb\u7597\u6027\u5ba3\u79f0\u6216\u91cd\u8981\u8bbe\u8ba1\u53d8\u66f4\uff0c\u90fd\u53ef\u80fd\u5f71\u54cd\u5224\u65ad\u3002<\/p>\n\n<p>\u5728\u7f8e\u56fd\u4e0a\u5e02\u524d\uff0c\u8bf7\u6838\u5bf9\u4ee5\u4e0b\u4e8b\u9879\uff1a<\/p>\n\n<ol>\n<li>\u4ea7\u54c1\u662f\u5426\u7b26\u5408\u53e3\u8154\u51b2\u6d17\u5668\u7c7b\u522b\uff1f<\/li>\n<li>\u9884\u671f\u7528\u9014\u662f\u5426\u7b26\u5408\u8be5\u7c7b\u522b\uff1f<\/li>\n<li>\u4ea7\u54c1\u5ba3\u79f0\u662f\u5426\u9650\u4e8e\u73b0\u6709\u8bc1\u636e\u548c\u6cd5\u89c4\u8def\u5f84\u6240\u652f\u6301\u7684\u8303\u56f4\uff1f<\/li>\n<li>\u5236\u9020\u5546\u3001\u8fdb\u53e3\u5546\u548c\u7ecf\u9500\u5546\u662f\u5426\u5206\u522b\u5c65\u884c\u5176\u89d2\u8272\u6240\u8981\u6c42\u7684\u804c\u8d23\uff1f<\/li>\n<li>\u6807\u7b7e\u3001\u7535\u6c14\u5b89\u5168\u3001\u751f\u7269\u76f8\u5bb9\u6027\u3001\u8f6f\u4ef6\u548c\u6027\u80fd\u6587\u4ef6\u662f\u5426\u9002\u7528\u4e8e\u8be5\u578b\u53f7\u53ca\u76ee\u6807\u5e02\u573a\uff1f<\/li>\n<\/ol>\n\n<p>\u8bf7\u7531\u8d1f\u8d23\u7684\u6cd5\u89c4\u4e13\u4e1a\u4eba\u5458\u6216\u7f8e\u56fd\u8fdb\u53e3\u5546\u786e\u8ba4\u6210\u54c1\u9002\u7528\u7684\u6cd5\u89c4\u8def\u5f84\u3002\u672c\u6587\u63d0\u4f9b\u7684\u662f\u89c4\u5212\u80cc\u666f\uff0c\u4e0d\u80fd\u66ff\u4ee3\u9488\u5bf9\u5177\u4f53\u4ea7\u54c1\u7684\u6cd5\u89c4\u8bc4\u4f30\u3002<\/p>\n\n<h2>OEM \u4e70\u5bb6\u5728\u7f8e\u56fd\u4e0a\u5e02\u524d\u5e94\u8be2\u95ee\u4ec0\u4e48<\/h2>\n\n<p>\u8bf7\u4f9b\u5e94\u5546\u8bf4\u660e\u53ef\u6838\u5b9e\u7684\u4ea7\u54c1\u4fe1\u606f\uff1a<\/p>\n\n<ul>\n<li><strong>\u9884\u671f\u7528\u9014\uff1a<\/strong> \u4f9b\u5e94\u5546\u79f0\u8be5\u5668\u68b0\u662f\u4e3a\u5b9e\u73b0\u4ec0\u4e48\u7528\u9014\u800c\u8bbe\u8ba1\u7684\uff1f<\/li>\n<li><strong>\u578b\u53f7\u8303\u56f4\uff1a<\/strong> \u6587\u4ef6\u6db5\u76d6\u54ea\u4e9b\u5177\u4f53\u578b\u53f7\u3001\u55b7\u5634\u5957\u88c5\u3001\u7535\u6c60\u914d\u7f6e\u548c\u914d\u4ef6\uff1f<\/li>\n<li><strong>\u8bc1\u636e\uff1a<\/strong> \u4ea7\u54c1\u5728\u9632\u6c34\u3001\u7535\u6c14\u5b89\u5168\u3001\u6750\u6599\u548c\u6027\u80fd\u65b9\u9762\u6709\u54ea\u4e9b\u6d4b\u8bd5\u4f9d\u636e\uff1f<\/li>\n<li><strong>\u6807\u7b7e\uff1a<\/strong> \u5305\u88c5\u4e0e\u7ebf\u4e0a\u5546\u54c1\u9875\u9762\u4e2d\u7684\u9884\u671f\u7528\u9014\u8bf4\u660e\u3001\u8b66\u544a\u3001\u4f7f\u7528\u8bf4\u660e\u548c\u8fdb\u53e3\u5546\u4fe1\u606f\u662f\u5426\u4e00\u81f4\uff1f<\/li>\n<li><strong>\u6cd5\u89c4\u89d2\u8272\uff1a<\/strong> \u54ea\u4e00\u65b9\u662f\u767b\u8bb0\u5236\u9020\u5546\uff0c\u54ea\u4e00\u65b9\u8d1f\u8d23\u8fdb\u53e3\uff0c\u8c01\u8d1f\u8d23\u7ef4\u62a4\u76f8\u5173\u8bb0\u5f55\uff1f<\/li>\n<li><strong>\u5ba3\u79f0\u7ba1\u7406\uff1a<\/strong> \u54ea\u4e9b\u8bf4\u6cd5\u5c5e\u4e8e\u4ea7\u54c1\u529f\u80fd\uff0c\u54ea\u4e9b\u4f1a\u6784\u6210\u533b\u7597\u6216\u4e34\u5e8a\u5ba3\u79f0\uff1f<\/li>\n<\/ul>\n\n<p>\u7b54\u590d\u5e94\u5bf9\u5e94\u60a8\u8ba1\u5212\u9500\u552e\u7684\u5177\u4f53\u578b\u53f7\u3002\u4f9b\u5e94\u5546\u7b3c\u7edf\u58f0\u79f0\u201c\u7b26\u5408 FDA \u8981\u6c42\u201d\uff0c\u5e76\u4e0d\u4f1a\u81ea\u52a8\u8986\u76d6\u65b0\u7684\u5916\u58f3\u3001\u6c34\u6cf5\u3001\u8f6f\u4ef6\u529f\u80fd\u6216\u4e0d\u540c\u7684\u5ba3\u79f0\u3002<\/p>\n\n<h2>FDA \u89c4\u5219\u53ea\u662f\u5e02\u573a\u51c6\u5165\u7684\u4e00\u90e8\u5206<\/h2>\n\n<p>\u7f8e\u56fd\u53ea\u662f\u4e00\u4e2a\u76ee\u6807\u5e02\u573a\u3002\u5982\u679c\u540c\u4e00\u6b3e\u51b2\u7259\u5668\u8fd8\u5c06\u5728\u6b27\u6d32\u3001\u82f1\u56fd\u6216\u5176\u4ed6\u5730\u533a\u9500\u552e\uff0c\u5e94\u4e3a\u6bcf\u4e2a\u5e02\u573a\u5355\u72ec\u5efa\u7acb\u5408\u89c4\u6e05\u5355\u3002\u4ea7\u54c1\u540d\u79f0\u3001\u9884\u671f\u7528\u9014\u3001\u7535\u6c14\u8981\u6c42\u3001\u6807\u7b7e\u548c\u7b26\u5408\u6027\u6587\u4ef6\u90fd\u53ef\u80fd\u56e0\u5e02\u573a\u800c\u5f02\u3002<\/p>\n\n<p>\u4e0d\u8981\u628a\u7f8e\u56fd EFS \u5206\u7c7b\u6269\u5c55\u6210\u201c\u5168\u7403\u83b7\u5f97 FDA \u6279\u51c6\u5e76\u53d6\u5f97\u533b\u7597\u8ba4\u8bc1\u201d\u4e4b\u7c7b\u7684\u8bf4\u6cd5\u3002\u7f8e\u56fd\u6cd5\u89c4\u8bf4\u660e\u5e94\u4e0e\u7f8e\u56fd\u5e02\u573a\u6765\u6e90\u4fe1\u606f\u5bf9\u5e94\uff1b\u5176\u4ed6\u5e02\u573a\u5219\u5e94\u6309\u5404\u81ea\u89c4\u5219\u8bc4\u4f30\u3002<\/p>\n\n<h2>Relish Tech \u5982\u4f55\u652f\u6301\u51b2\u7259\u5668\u9879\u76ee<\/h2>\n\n<p>Relish Tech \u4e3a\u53e3\u8154\u62a4\u7406\u4ea7\u54c1\u63d0\u4f9b OEM\/ODM \u652f\u6301\uff0c\u5305\u62ec\u4ea7\u54c1\u8bbe\u8ba1\u3001\u5de5\u7a0b\u5f00\u53d1\u3001\u539f\u578b\u5236\u4f5c\u3001\u6a21\u5177\u5f00\u53d1\u3001\u7ec4\u88c5\u3001\u5305\u88c5\u548c\u9488\u5bf9\u5177\u4f53\u578b\u53f7\u7684\u6d4b\u8bd5\u534f\u8c03\u3002\u5176 <a href=\"https:\/\/relish-tech.com\/cn\/%e8%ae%a4%e8%af%81\/\">\u8ba4\u8bc1\u4e0e\u8d28\u91cf\u4fe1\u606f\u9875\u9762<\/a> \u53ef\u4f5c\u4e3a\u4e86\u89e3\u516c\u53f8\u8d28\u91cf\u4f53\u7cfb\u53ca\u73b0\u6709\u5408\u89c4\u652f\u6301\u7684\u8d77\u70b9\u3002<\/p>\n\n<p>\u51b2\u7259\u5668\u9879\u76ee\u7684\u7b2c\u4e00\u6b65\u662f\u660e\u786e\u578b\u53f7\u548c\u76ee\u6807\u5e02\u573a\u3002\u4e4b\u540e\uff0cRelish \u53ef\u534f\u52a9\u54c1\u724c\u65b9\u8ba8\u8bba\u6240\u9009\u8def\u5f84\u6d89\u53ca\u7684\u6c34\u6cf5\u3001\u6c34\u7bb1\u3001\u7535\u6c60\u3001\u55b7\u5634\u5957\u88c5\u3001\u5145\u7535\u65b9\u5f0f\u3001\u5916\u58f3\u3001\u5305\u88c5\u548c\u6587\u4ef6\u3002\u6cd5\u89c4\u652f\u6301\u5e94\u7406\u89e3\u4e3a\u9879\u76ee\u534f\u52a9\uff1b\u8fd9\u5e76\u4e0d\u610f\u5473\u7740 FDA \u5df2\u6279\u51c6\u4f9b\u5e94\u5546\u5236\u9020\u7684\u6bcf\u4e00\u6b3e\u4ea7\u54c1\u3002<\/p>\n\n<p class=\"translation-block\">\u5982\u6709\u4ea7\u54c1\u65b9\u9762\u7684\u95ee\u9898\uff0c\u8bf7\u53c2\u9605<a href=\"https:\/\/relish-tech.com\/cn\/%e6%b0%b4%e5%86%b2%e6%b4%97%e5%99%a8-oem-odm-%e8%b4%ad%e4%b9%b0%e6%8c%87%e5%8d%97\/\" target=\"_self\">\u51b2\u7259\u5668 OEM\/ODM \u91c7\u8d2d\u6307\u5357<\/a>\uff0c\u6216<a href=\"https:\/\/relish-tech.com\/cn\/%e8%81%94%e7%b3%bb\/\" target=\"_self\">\u8054\u7cfb Relish Tech<\/a>\u3002<\/p>\n\n<p>\u5982\u9700\u6839\u636e\u578b\u53f7\u3001\u914d\u7f6e\u548c\u8ba2\u5355\u8981\u6c42\u83b7\u53d6\u5de5\u5382\u76f4\u4f9b\u62a5\u4ef7\uff0c\u8bf7\u8054\u7cfb Relish Tech\u3002<\/p>\n\n<h2>\u5e38\u89c1\u95ee\u9898<\/h2>\n\n<h3>\u5728\u7f8e\u56fd\uff0c\u51b2\u7259\u5668\u5c5e\u4e8e\u533b\u7597\u5668\u68b0\u5417\uff1f<\/h3>\n\n<p>FDA \u5c06\u53e3\u8154\u51b2\u6d17\u5668\u5217\u5165 EFS \u4ea7\u54c1\u4ee3\u7801\uff0c\u5f52\u4e3a I \u7c7b\u533b\u7597\u5668\u68b0\u7c7b\u522b\u3002\u5177\u4f53\u578b\u53f7\u662f\u5426\u7b26\u5408\u8be5\u7c7b\u522b\uff0c\u53d6\u51b3\u4e8e\u5176\u9884\u671f\u7528\u9014\u3001\u5ba3\u79f0\u548c\u8bbe\u8ba1\u3002<\/p>\n\n<h3>FDA \u6ce8\u518c\u662f\u5426\u610f\u5473\u7740 FDA \u5df2\u6279\u51c6\u8fd9\u6b3e\u51b2\u7259\u5668\uff1f<\/h3>\n\n<p>\u4e0d\u662f\u3002\u6ce8\u518c\u548c\u5668\u68b0\u5217\u540d\u4e0d\u540c\u4e8e FDA \u8bb8\u53ef\u6216\u6279\u51c6\u3002FDA \u4e0d\u4f1a\u7b7e\u53d1\u901a\u7528\u7684\u533b\u7597\u5668\u68b0\u6ce8\u518c\u8bc1\u4e66\u3002<\/p>\n\n<h3>\u6bcf\u6b3e\u51b2\u7259\u5668\u90fd\u9700\u8981 510(k) \u5417\uff1f<\/h3>\n\n<p>\u4e0d\u662f\u3002EFS \u7c7b\u522b\u901a\u5e38\u8c41\u514d 510(k) \u4e0a\u5e02\u524d\u901a\u77e5\uff0c\u4f46\u4ecd\u53d7\u9002\u7528\u9650\u5236\u3002\u8bf7\u9488\u5bf9\u5177\u4f53\u578b\u53f7\u548c\u9884\u671f\u7528\u9014\u786e\u8ba4\u6cd5\u89c4\u8def\u5f84\u3002<\/p>\n\n<h3>OEM \u4e70\u5bb6\u9996\u5148\u5e94\u786e\u8ba4\u4ec0\u4e48\uff1f<\/h3>\n\n<p>\u786e\u8ba4\u4ea7\u54c1\u7684\u9884\u671f\u7528\u9014\u3001\u578b\u53f7\u914d\u7f6e\u3001\u5ba3\u79f0\u3001\u8d1f\u8d23\u7684\u5236\u9020\u5546\u548c\u8fdb\u53e3\u5546\u3001\u6807\u7b7e\u3001\u6d4b\u8bd5\u6587\u4ef6\uff0c\u4ee5\u53ca\u76ee\u6807\u5e02\u573a\u9002\u7528\u7684\u6cd5\u89c4\u8def\u5f84\u3002<\/p>\n\n<h3>OEM \u51b2\u7259\u5668\u9879\u76ee\u5e94\u6309\u591a\u5c11\u6700\u4f4e\u8d77\u8ba2\u91cf\u89c4\u5212\uff1f<\/h3>\n\n<p>Relish Tech \u7684\u6807\u51c6 MOQ \u4e3a <strong>1,000\u4ef6<\/strong>\u3002\u8bf7\u4e0e\u6211\u4eec\u7684\u56e2\u961f\u8ba8\u8bba\u60a8\u7684\u914d\u7f6e\u548c\u9879\u76ee\u8981\u6c42\u3002<\/p>\n\n<h2>\u53c2\u8003\u8d44\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 EFS \u4ea7\u54c1\u4ee3\u7801\uff1a\u53e3\u8154\u51b2\u6d17\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\uff1a\u662f\u5426\u5b58\u5728 FDA \u6ce8\u518c\u6216 FDA \u8ba4\u8bc1\u7684\u533b\u7597\u5668\u68b0\uff1f<\/a><\/li>\n<li><a href=\"https:\/\/relish-tech.com\/cn\/%e8%ae%a4%e8%af%81\/\">Relish Tech \u8ba4\u8bc1\u4e0e\u8d28\u91cf\u4fe1\u606f<\/a><\/li>\n<li><a href=\"https:\/\/relish-tech.com\/cn\/%e6%b0%b4%e5%86%b2%e6%b4%97%e5%99%a8-oem-odm-%e8%b4%ad%e4%b9%b0%e6%8c%87%e5%8d%97\/\">Relish Tech \u51b2\u7259\u5668 OEM\/ODM \u91c7\u8d2d\u6307\u5357<\/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\/cn\/wp-json\/wp\/v2\/posts\/3973","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/relish-tech.com\/cn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/relish-tech.com\/cn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/relish-tech.com\/cn\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/relish-tech.com\/cn\/wp-json\/wp\/v2\/comments?post=3973"}],"version-history":[{"count":5,"href":"https:\/\/relish-tech.com\/cn\/wp-json\/wp\/v2\/posts\/3973\/revisions"}],"predecessor-version":[{"id":8413,"href":"https:\/\/relish-tech.com\/cn\/wp-json\/wp\/v2\/posts\/3973\/revisions\/8413"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/relish-tech.com\/cn\/wp-json\/wp\/v2\/media\/8527"}],"wp:attachment":[{"href":"https:\/\/relish-tech.com\/cn\/wp-json\/wp\/v2\/media?parent=3973"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/relish-tech.com\/cn\/wp-json\/wp\/v2\/categories?post=3973"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/relish-tech.com\/cn\/wp-json\/wp\/v2\/tags?post=3973"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}