{"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":"%eb%ac%bc-%ec%b9%98%ec%8b%a4%ec%9d%80-%ec%9d%98%eb%a3%8c-%ea%b8%b0%ea%b8%b0%ec%9d%b8%ea%b0%80%ec%9a%94","status":"publish","type":"post","link":"https:\/\/relish-tech.com\/kr\/is-the-water-flosser-a-medical-device\/","title":{"rendered":"\uad6c\uac15\uc138\uc815\uae30\ub294 \uc758\ub8cc\uae30\uae30\uc77c\uae4c? \ubbf8\uad6d \uc2dc\uc7a5 \uc9c4\ucd9c\uc744 \uc704\ud55c FDA \uaddc\uc815"},"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>\ubbf8\uad6d FDA\ub294 \uad6c\uac15\uc138\uc815\uae30\ub97c \uc81c\ud488 \ucf54\ub4dc EFS\uc5d0 \ub530\ub978 Class I(1\ub4f1\uae09) \uc758\ub8cc\uae30\uae30 \ubc94\uc8fc\ub85c \ub4f1\uc7ac\ud569\ub2c8\ub2e4. \uac1c\ubcc4 \uc81c\ud488\uc774 \uc774 \ubc94\uc8fc\uc5d0 \ud574\ub2f9\ud558\ub294\uc9c0\ub294 \uc0ac\uc6a9 \ubaa9\uc801, \uc124\uacc4, \ud45c\uc2dc\u00b7\uad11\uace0 \ub0b4\uc6a9\uc5d0 \ub530\ub77c \ub2ec\ub77c\uc9d1\ub2c8\ub2e4. \ub4f1\ub85d\uc774 \ud544\uc694\ud55c \uacbd\uc6b0\uc5d0\ub3c4 \uc774\ub97c FDA \uc2b9\uc778\uacfc \uad6c\ubd84\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n<h2>FDA \ubd84\ub958\uac00 \uc54c\ub824 \uc8fc\ub294 \ub0b4\uc6a9<\/h2>\n\n<p>\uad6c\uac15\uc138\uc815\uae30\ub294 \uce58\uc544 \uc0ac\uc774\uc640 \uce58\uc544\u00b7\uc787\ubab8\uc758 \uacbd\uacc4\ub97c \ub530\ub77c \ubb3c\uc744 \ubd84\uc0ac\ud569\ub2c8\ub2e4. \uaddc\uc81c \uc801\uc6a9 \uc5ec\ubd80\ub294 \uc138\uc815 \ubc29\uc2dd\ub9cc\uc774 \uc544\ub2c8\ub77c \uc644\uc81c\ud488\uacfc \uadf8 \uc0ac\uc6a9 \ubaa9\uc801\uc744 \uae30\uc900\uc73c\ub85c \ud310\ub2e8\ud569\ub2c8\ub2e4.<\/p>\n\n<p>FDA \uc758\ub8cc\uae30\uae30 \ubd84\ub958 \ub370\uc774\ud130\ubca0\uc774\uc2a4\uc5d0\ub294 \uad6c\uac15\uc138\uc815\uae30\uac00 \uc81c\ud488 \ucf54\ub4dc EFS\ub85c \ub4f1\uc7ac\ub418\uc5b4 \uc788\uc2b5\ub2c8\ub2e4. \ud574\ub2f9 \ud56d\ubaa9\uc740 Class I \ubc94\uc8fc\ub97c \ub098\ud0c0\ub0b4\uba70, \uae30\uae30\uc640 \uc0ac\uc6a9 \ubaa9\uc801\uc5d0 \uc801\uc6a9\ub418\ub294 \uc81c\ud55c\uc744 \uc804\uc81c\ub85c \uc77c\ubc18\uc801\uc73c\ub85c 510(k) \uc2dc\ud310 \uc804 \uc2e0\uace0\uac00 \uba74\uc81c\ub429\ub2c8\ub2e4.<\/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=\"\uc695\uc2e4\uc758 \ud0c1\uc0c1\ud615 \uad6c\uac15\uc138\uc815\uae30\uc640 \uc5ec\ud589\uc6a9 \ud30c\uc6b0\uce58 \uc606\uc5d0 \ub193\uc778 \ud734\ub300\uc6a9 \uad6c\uac15\uc138\uc815\uae30\ub97c \ubcf4\uc5ec \uc8fc\ub294 \uc77c\ub7ec\uc2a4\ud2b8.\" 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>\uc774 \ubd84\ub958\ub294 \uc81c\ud488\uc5d0 \uc801\uc6a9\ub418\ub294 \uaddc\uc81c\ub97c \uac80\ud1a0\ud560 \ub54c\uc758 \ucd9c\ubc1c\uc810\uc785\ub2c8\ub2e4. \ud38c\ud504\uc640 \ub178\uc990\uc774 \uc788\ub2e4\uace0 \ud574\uc11c \ubaa8\ub4e0 \uc81c\ud488\uc5d0 \uac19\uc740 \uaddc\uc81c\uac00 \uc801\uc6a9\ub418\ub294 \uac83\uc740 \uc544\ub2d9\ub2c8\ub2e4. \ud544\uc694\ud55c \uc808\ucc28\ub97c \uacb0\uc815\ud558\uae30 \uc804\uc5d0 \ub2e4\uc74c \uc0ac\ud56d\uc744 \ubb38\uc11c\ud654\ud558\uc138\uc694.<\/p>\n\n<ul>\n<li>\uc81c\ud488\uc758 \uc0ac\uc6a9 \ubaa9\uc801<\/li>\n<li>\ub204\uac00 \uc0ac\uc6a9\ud558\uace0 \uc5b4\ub514\uc5d0\uc11c \ud310\ub9e4\ud560\uc9c0<\/li>\n<li>\ub77c\ubca8, \ud3ec\uc7a5 \ubc0f \uc6f9\uc0ac\uc774\ud2b8\uc5d0 \ud45c\uc2dc\ud560 \ubb38\uad6c<\/li>\n<li>\ud45c\uc900 \uad6c\uac15\uc138\uc815\uae30\uc778\uc9c0 \ucd94\uac00 \uc758\ub8cc \ubaa9\uc801\uc774 \uc788\ub294 \uc81c\ud488\uc778\uc9c0<\/li>\n<li>\ubbf8\uad6d \ud310\ub9e4\uc6a9 \uc81c\ud488\uc758 \uc81c\uc870, \uc218\uc785, \uc720\ud1b5\uc744 \ub2f4\ub2f9\ud560 \uc0ac\uc5c5\uc790<\/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\uc758 EFS \ubd84\ub958 \uc815\ubcf4<\/a>\uc640 \ud574\ub2f9 \uc81c\ud488\uc5d0 \uc801\uc6a9\ub418\ub294 \uc694\uac74\uc744 \ud568\uaed8 \ud655\uc778\ud558\uc138\uc694. \ubd84\ub958 \ucf54\ub4dc\ub294 \ud310\ub2e8\uc5d0 \ub3c4\uc6c0\uc774 \ub418\ub294 \uc790\ub8cc\uc774\uc9c0\ub9cc, \ubaa8\ub4e0 \ubaa8\ub378\uc5d0 \ub300\ud55c \ud3ec\uad04\uc801 \uc2b9\uc778\uc744 \uc758\ubbf8\ud558\uc9c0\ub294 \uc54a\uc2b5\ub2c8\ub2e4.<\/p>\n\n<h2>FDA \ub4f1\ub85d\uc740 FDA \uc2b9\uc778\uc774 \uc544\ub2d9\ub2c8\ub2e4<\/h2>\n\n<p>\uc0ac\uc5c5\uc7a5 \ub4f1\ub85d, \uae30\uae30 \ub4f1\uc7ac, \uc2dc\ud310 \uc804 \uc2ec\uc0ac\ub294 \uc11c\ub85c \ub2e4\ub978 \uc808\ucc28\uc785\ub2c8\ub2e4.<\/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=\"\uae30\uc220\uc790\uac00 \uc791\uc5c5\ub300\uc5d0\uc11c \uad6c\uac15\uc138\uc815\uae30 \ubb3c\ud1b5\uc758 \uc5f0\uacb0\ubd80\uc640 \ubc00\ubd09 \ubd80\ud488\uc744 \uc810\uac80\ud558\ub294 \uc77c\ub7ec\uc2a4\ud2b8.\" 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>\uc0ac\uc5c5\uc7a5\uc774 \ub4f1\ub85d\ub418\uace0 \uae30\uae30\uac00 FDA \uc2dc\uc2a4\ud15c\uc5d0 \ub4f1\uc7ac\ub418\uc5b4 \uc788\uc5b4\ub3c4 FDA\uc758 \uc2dc\ud310\ud5c8\uac00(clearance)\ub098 \uc2b9\uc778(approval)\uc744 \ubc1b\uc558\ub2e4\ub294 \ub73b\uc740 \uc544\ub2d9\ub2c8\ub2e4. FDA\ub294 \uc758\ub8cc\uae30\uae30\uc5d0 \ub300\ud574 \uc77c\ubc18\uc801\uc778 \u201cFDA \ub4f1\ub85d\uc99d\uba85\uc11c\u201d\ub97c \ubc1c\uae09\ud558\uc9c0 \uc54a\ub294\ub2e4\uace0 \uc124\uba85\ud569\ub2c8\ub2e4. \ub4f1\ub85d \uae30\ub85d\ub9cc\uc73c\ub85c FDA\uac00 \uc81c\ud488\uc758 \uc548\uc804\uc131\uc774\ub098 \uc131\ub2a5\uc744 \uc2ec\uc0ac\ud588\ub2e4\uace0 \uc785\uc99d\ud560 \uc218\ub3c4 \uc5c6\uc2b5\ub2c8\ub2e4.<\/p>\n\n<p>\uacf5\uae09\uc5c5\uccb4\ub098 \uc81c3\uc790\uac00 \ubc1c\uae09\ud55c \ub4f1\ub85d\uc99d\uba85\uc11c\ub294 FDA \uc2b9\uc778\uc744 \ub73b\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \uacf5\uae09\uc5c5\uccb4 \ubb38\uc11c\ub97c \uac80\ud1a0\ud560 \ub54c\ub294 \ub2e4\uc74c \ud45c\ud604\uc744 \uad6c\ubd84\ud558\uc138\uc694.<\/p>\n\n<ul>\n<li>\u201c\uc81c\ud488\uc774 FDA \uc81c\ud488 \ucf54\ub4dc EFS\uc5d0 \ub530\ub77c \ud3c9\uac00 \uc911\u201d\uc740 \uaddc\uc81c \uacc4\ud68d \ub2e8\uacc4\uc5d0 \ub300\ud55c \uc124\uba85\uc785\ub2c8\ub2e4.<\/li>\n<li>\u201c\uc2dc\uc124\uc774 \ub4f1\ub85d\ub418\uace0 \uae30\uae30\uac00 \ub4f1\uc7ac\ub428\u201d\uc740 \uae30\ub85d\uc744 \uc124\uba85\ud558\ub294 \uac83\uc774\uba70 \uc2b9\uc778\uc744 \ub73b\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/li>\n<li>\u201cFDA cleared(\uc2dc\ud310\ud5c8\uac00 \ucde8\ub4dd)\u201d \ub610\ub294 \u201cFDA approved(\uc2b9\uc778 \ucde8\ub4dd)\u201d\ub77c\ub294 \ud45c\ud604\uc740 \ud574\ub2f9 \uc81c\ud488\uacfc \uc801\uc6a9 \uc808\ucc28\uac00 \uadf8 \ub0b4\uc6a9\uc744 \ub4b7\ubc1b\uce68\ud560 \ub54c\ub9cc \uc0ac\uc6a9\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n<p class=\"translation-block\"><p>\uc81c\ud488 \ud398\uc774\uc9c0\ub098 \uc601\uc5c5 \uc790\ub8cc\uc5d0 \ub4f1\ub85d \uad00\ub828 \ud45c\ud604\uc744 \uc0ac\uc6a9\ud558\uae30 \uc804\uc5d0, <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\">\ub4f1\ub85d\u00b7\uc778\uc99d \uc758\ub8cc\uae30\uae30\uc5d0 \uad00\ud55c FDA\uc758 \uc124\uba85<\/a>\uc744 \ud655\uc778\ud558\uc138\uc694.<\/p><\/p>\n\n<h2>\ub4f1\ub85d\uacfc \ub4f1\uc7ac\ub294 \ub204\uac00 \ub2f4\ub2f9\ud558\ub098\uc694?<\/h2>\n\n<p>FDA\ub294 21 CFR Part 807\uc5d0 \ub530\ub77c \uc0ac\uc5c5\uc7a5 \ub4f1\ub85d\uacfc \uae30\uae30 \ub4f1\uc7ac \uc694\uac74\uc744 \uc815\ud569\ub2c8\ub2e4. <a href=\"https:\/\/www.fda.gov\/medical-devices\/device-registration-and-listing\/who-must-register-list-and-pay-fee\" target=\"_blank\" rel=\"noopener\">\uc0ac\uc5c5 \ud65c\ub3d9\ubcc4 \uc694\uac74\ud45c\uc5d0\uc11c\ub294<\/a> \uc81c\uc870\uc5c5\uccb4, \uc704\ud0c1 \uc81c\uc870\uc5c5\uccb4, \ucd5c\ucd08 \uc218\uc785\uc5c5\uccb4(initial importer), \uc720\ud1b5\uc5c5\uccb4\ub97c \uad6c\ubd84\ud569\ub2c8\ub2e4. \uc608\ub97c \ub4e4\uc5b4 \ud574\uc678 \uc644\uc81c\ud488 \uc81c\uc870\uc5c5\uccb4\ub294 \uc77c\ubc18\uc801\uc73c\ub85c \ub4f1\ub85d\uacfc \ub4f1\uc7ac\ub97c \uc9c4\ud589\ud569\ub2c8\ub2e4. \ubc18\uba74 \ucd5c\ucd08 \uc218\uc785\uc5c5\uccb4\ub294 \ub4f1\ub85d\ud558\uace0 \uc81c\uc870\uc5c5\uccb4 \uc815\ubcf4\ub97c \uc2e0\uace0\ud558\uc9c0\ub9cc, \uae30\uae30 \uc790\uccb4\ub97c \ub4f1\uc7ac\ud558\uc9c0\ub294 \uc54a\uc2b5\ub2c8\ub2e4. \uc218\uc785\uc744 \ud558\uc9c0 \uc54a\ub294 \ubbf8\uad6d \ub0b4 \uc720\ud1b5\uc5c5\uccb4\uc5d0\ub294 \ub2e4\ub978 \uc5ed\ud560\uc774 \uc801\uc6a9\ub429\ub2c8\ub2e4.<\/p>\n\n<p>\ucd9c\ud558 \uc804\uc5d0 \uac01\uc790\uc758 \ucc45\uc784\uc744 \ud569\uc758\ud558\uc138\uc694. \ud3ec\uc7a5\uc5d0 \ud45c\uc2dc\ub41c \ube0c\ub79c\ub4dc\uba85\ub9cc\uc73c\ub85c \uac01 \uc0ac\uc5c5\uc790\uc758 \uaddc\uc81c\uc0c1 \uc5ed\ud560\uc744 \uc54c \uc218\ub294 \uc5c6\uc2b5\ub2c8\ub2e4.<\/p>\n\n<h2>\ubaa8\ub4e0 \uad6c\uac15\uc138\uc815\uae30\uc5d0 510(k)\uac00 \ud544\uc694\ud55c\uac00\uc694?<\/h2>\n\n<p>\ubc18\ub4dc\uc2dc \ud544\uc694\ud55c \uac83\uc740 \uc544\ub2d9\ub2c8\ub2e4. EFS \ubc94\uc8fc\ub294 \uc77c\ubc18\uc801\uc73c\ub85c 510(k) \uba74\uc81c \ub300\uc0c1\uc774\uc9c0\ub9cc \uba74\uc81c\uc5d0\ub294 \uc81c\ud55c\uc774 \uc788\uc2b5\ub2c8\ub2e4. \uc0c8 \ubaa8\ub378, \ub2e4\ub978 \uc0ac\uc6a9 \ubaa9\uc801, \uce58\ub8cc \ud6a8\uacfc\ub97c \ub0b4\uc138\uc6b0\ub294 \ud45c\uc2dc\u00b7\uad11\uace0, \uc911\uc694\ud55c \uc124\uacc4 \ubcc0\uacbd\uc740 \ud310\ub2e8\uc5d0 \uc601\ud5a5\uc744 \uc904 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n<p>\ubbf8\uad6d \ucd9c\uc2dc \uc804\uc5d0 \ub2e4\uc74c \uc0ac\ud56d\uc744 \ud655\uc778\ud558\uc138\uc694.<\/p>\n\n<ol>\n<li>\uc81c\ud488\uc774 \uad6c\uac15\uc138\uc815\uae30 \ubc94\uc8fc\uc5d0 \ud574\ub2f9\ud558\ub098\uc694?<\/li>\n<li>\uc0ac\uc6a9 \ubaa9\uc801\uc774 \ud574\ub2f9 \ubc94\uc8fc\uc640 \uc77c\uce58\ud558\ub098\uc694?<\/li>\n<li>\ud45c\uc2dc\u00b7\uad11\uace0 \ub0b4\uc6a9\uc774 \ud574\ub2f9 \uc81c\ud488\uc758 \uadfc\uac70 \uc790\ub8cc\uc640 \uc801\uc6a9 \uac00\ub2a5\ud55c \uaddc\uc81c \uc808\ucc28\uac00 \ub4b7\ubc1b\uce68\ud558\ub294 \ubc94\uc704\uc5d0 \ud55c\uc815\ub418\uc5b4 \uc788\ub098\uc694?<\/li>\n<li>\uc81c\uc870\uc5c5\uccb4, \uc218\uc785\uc5c5\uccb4 \ubc0f \uc720\ud1b5\uc5c5\uccb4\uac00 \uac01 \uc5ed\ud560\uc5d0 \ud544\uc694\ud55c \ucc45\uc784\uc744 \ub9e1\uace0 \uc788\ub098\uc694?<\/li>\n<li>\ud45c\uc2dc, \uc804\uae30 \uc548\uc804, \uc0dd\uccb4\uc801\ud569\uc131, \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ubc0f \uc131\ub2a5 \uc790\ub8cc\uac00 \ud574\ub2f9 \ubaa8\ub378\uacfc \uc2dc\uc7a5\uc5d0 \uc801\ud569\ud55c\uac00\uc694?<\/li>\n<\/ol>\n\n<p>\uc644\uc81c\ud488\uc5d0 \uc801\uc6a9\ub418\ub294 \uc808\ucc28\ub294 \ub2f4\ub2f9 \uaddc\uc81c \uc804\ubb38\uac00\ub098 \ubbf8\uad6d \uc218\uc785\uc5c5\uccb4\uc5d0 \ud655\uc778\ud558\uc138\uc694. \uc774 \uae00\uc740 \uacc4\ud68d \uc218\ub9bd\uc744 \uc704\ud55c \ucc38\uace0 \uc815\ubcf4\uc774\uba70, \uc81c\ud488\ubcc4 \uaddc\uc81c \ud3c9\uac00\ub97c \ub300\uc2e0\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/p>\n\n<h2>\ubbf8\uad6d \ucd9c\uc2dc \uc804\uc5d0 OEM \uad6c\ub9e4\uc790\uac00 \ud655\uc778\ud560 \uc0ac\ud56d<\/h2>\n\n<p>\uacf5\uae09\uc5c5\uccb4\uc5d0 \ud655\uc778 \uac00\ub2a5\ud55c \ubc29\uc2dd\uc73c\ub85c \uc81c\ud488\uc744 \uc124\uba85\ud574 \ub2ec\ub77c\uace0 \uc694\uccad\ud558\uc138\uc694.<\/p>\n\n<ul>\n<li><strong>\uc0ac\uc6a9 \ubaa9\uc801:<\/strong> \uacf5\uae09\uc5c5\uccb4\ub294 \uae30\uae30\ub97c \uc5b4\ub5a4 \uc6a9\ub3c4\ub85c \uc124\uacc4\ud588\ub2e4\uace0 \uc124\uba85\ud558\ub098\uc694?<\/li>\n<li><strong>\ub300\uc0c1 \ubaa8\ub378:<\/strong> \uc5b4\ub5a4 \ubaa8\ub378, \ub178\uc990 \uc138\ud2b8, \ubc30\ud130\ub9ac \uad6c\uc131, \ubd80\uc18d\ud488\uc774 \uc790\ub8cc\uc758 \uc801\uc6a9 \ub300\uc0c1\uc778\uac00\uc694?<\/li>\n<li><strong>\uadfc\uac70 \uc790\ub8cc:<\/strong> \ubc29\uc218\uc131, \uc804\uae30 \uc548\uc804, \uc7ac\ub8cc, \uc131\ub2a5\uc744 \ub4b7\ubc1b\uce68\ud558\ub294 \uc2dc\ud5d8\uc740 \ubb34\uc5c7\uc778\uac00\uc694?<\/li>\n<li><strong>\ud45c\uc2dc \uc0ac\ud56d:<\/strong> \uc0ac\uc6a9 \ubaa9\uc801, \uacbd\uace0, \uc0ac\uc6a9 \uc124\uba85, \uc218\uc785\uc5c5\uccb4 \uc815\ubcf4\uac00 \ud3ec\uc7a5\uacfc \uc628\ub77c\uc778 \ud310\ub9e4 \ud398\uc774\uc9c0\uc5d0\uc11c \uc77c\uce58\ud558\ub098\uc694?<\/li>\n<li><strong>\uaddc\uc81c\uc0c1 \uc5ed\ud560:<\/strong> \uacf5\uc2dd \uc790\ub8cc\uc0c1 \uc81c\uc870\uc5c5\uccb4\ub294 \ub204\uad6c\uc774\uba70, \ub204\uac00 \uc218\uc785\ud558\uace0 \uad00\ub828 \uae30\ub85d\uc744 \ubcf4\uad00\ud558\ub098\uc694?<\/li>\n<li><strong>\ud45c\uc2dc\u00b7\uad11\uace0 \uad00\ub9ac:<\/strong> \uc5b4\ub5a4 \ud45c\ud604\uc774 \uc81c\ud488 \ud2b9\uc9d5\uc744 \uc124\uba85\ud558\uba70, \uc5b4\ub5a4 \ud45c\ud604\uc774 \uc758\ub8cc\uc801\u00b7\uc784\uc0c1\uc801 \ud6a8\ub2a5\uc744 \uc8fc\uc7a5\ud558\ub098\uc694?<\/li>\n<\/ul>\n\n<p>\ub2f5\ubcc0\uc774 \ud310\ub9e4\ud558\ub824\ub294 \ubaa8\ub378\uc5d0 \uad00\ud55c \uac83\uc778\uc9c0 \ud655\uc778\ud558\uc138\uc694. \uacf5\uae09\uc5c5\uccb4\uc758 \uc77c\ubc18\uc801\uc778 \u201cFDA \uaddc\uc815 \uc900\uc218\u201d \uc124\uba85\uc774 \uc0c8\ub85c\uc6b4 \ud558\uc6b0\uc9d5, \ud38c\ud504, \uc18c\ud504\ud2b8\uc6e8\uc5b4 \uae30\ub2a5\uc774\ub098 \ub2e4\ub978 \ud45c\uc2dc\u00b7\uad11\uace0 \ub0b4\uc6a9\uae4c\uc9c0 \uc790\ub3d9\uc73c\ub85c \ud3ec\ud568\ud558\uc9c0\ub294 \uc54a\uc2b5\ub2c8\ub2e4.<\/p>\n\n<h2>FDA \uaddc\uc815\uc740 \uc2dc\uc7a5 \uc9c4\uc785 \uc694\uac74\uc758 \uc77c\ubd80\uc785\ub2c8\ub2e4<\/h2>\n\n<p>\ubbf8\uad6d\uc740 \uc5ec\ub7ec \uc2dc\uc7a5 \uc911 \ud558\ub098\uc785\ub2c8\ub2e4. \uac19\uc740 \uad6c\uac15\uc138\uc815\uae30\ub97c \uc720\ub7fd, \uc601\uad6d \ub610\ub294 \ub2e4\ub978 \uc9c0\uc5ed\uc5d0\uc11c \ud310\ub9e4\ud55c\ub2e4\uba74 \uac01 \ud310\ub9e4 \uc9c0\uc5ed\ubcc4\ub85c \ubcc4\ub3c4\uc758 \uc801\ud569\uc131 \uccb4\ud06c\ub9ac\uc2a4\ud2b8\ub97c \uc791\uc131\ud558\uc138\uc694. \uc81c\ud488\uba85, \uc0ac\uc6a9 \ubaa9\uc801, \uc804\uae30 \uc694\uac74, \ud45c\uc2dc \ubc0f \uc801\ud569\uc131 \ubb38\uc11c\ub294 \uc2dc\uc7a5\ub9c8\ub2e4 \ub2e4\ub97c \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n<p>\ubbf8\uad6d EFS \ubd84\ub958\ub97c \u201cFDA \uc2b9\uc778 \ubc0f \uc804 \uc138\uacc4 \uc758\ub8cc \uc778\uc99d \uc644\ub8cc\u201d\uc640 \uac19\uc740 \uae00\ub85c\ubc8c \ubb38\uad6c\ub85c \ubc14\uafb8\uc9c0 \ub9c8\uc138\uc694. \ubbf8\uad6d \uaddc\uc81c \uc124\uba85\uc740 \ubbf8\uad6d \uadfc\uac70 \uc790\ub8cc\uc5d0 \ub9de\ucd94\uace0, \ub2e4\ub978 \uc2dc\uc7a5\uc740 \uac01 \uc9c0\uc5ed\uc758 \uaddc\uc815\uc5d0 \ub530\ub77c \ud3c9\uac00\ud558\uc138\uc694.<\/p>\n\n<h2>\uad6c\uac15\uc138\uc815\uae30 \ud504\ub85c\uc81d\ud2b8\uc5d0\uc11c Relish Tech\uac00 \uc9c0\uc6d0\ud560 \uc218 \uc788\ub294 \ub0b4\uc6a9<\/h2>\n\n<p>Relish Tech\ub294 \uad6c\uac15\uad00\ub9ac \uc81c\ud488\uc758 OEM\/ODM \ud504\ub85c\uc81d\ud2b8\uc5d0\uc11c \uc81c\ud488 \uc124\uacc4, \uc5d4\uc9c0\ub2c8\uc5b4\ub9c1, \uc2dc\uc81c\ud488 \uc81c\uc791, \uae08\ud615 \uc81c\uc791, \uc870\ub9bd, \ud3ec\uc7a5, \ubaa8\ub378\ubcc4 \uc2dc\ud5d8 \uc870\uc728\uc744 \uc9c0\uc6d0\ud569\ub2c8\ub2e4. \ud68c\uc0ac\uc758 \ud488\uc9c8 \uc2dc\uc2a4\ud15c\uacfc \uc81c\uacf5 \uac00\ub2a5\ud55c \uaddc\uc81c \uc900\uc218 \uc9c0\uc6d0\uc740 <a href=\"https:\/\/relish-tech.com\/kr\/%ec%9d%b8%ec%a6%9d\/\">\uc778\uc99d \ubc0f \ud488\uc9c8 \ud398\uc774\uc9c0\uc5d0\uc11c<\/a> \ud655\uc778\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n<p>\uad6c\uac15\uc138\uc815\uae30 \ud504\ub85c\uc81d\ud2b8\uc5d0\uc11c\ub294 \uc6b0\uc120 \ubaa8\ub378\uacfc \ub300\uc0c1 \uc2dc\uc7a5\uc744 \uc815\ud569\ub2c8\ub2e4. \uc774\ud6c4 \uc120\ud0dd\ud55c \uaddc\uc81c \uacbd\ub85c\uc5d0 \ud544\uc694\ud55c \ud38c\ud504, \ubb3c\ud1b5, \ubc30\ud130\ub9ac, \ub178\uc990 \uc138\ud2b8, \ucda9\uc804 \ubc29\uc2dd, \ud558\uc6b0\uc9d5, \ud3ec\uc7a5 \ubc0f \ubb38\uc11c\uc5d0 \ub300\ud574 \ube0c\ub79c\ub4dc\uc640 \ud611\uc758\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uaddc\uc81c \uc9c0\uc6d0\uc740 \ud504\ub85c\uc81d\ud2b8 \uc9c0\uc6d0\uc744 \ub73b\ud558\uba70 \uacf5\uae09\uc5c5\uccb4\uac00 \uc81c\uc870\ud55c \ubaa8\ub4e0 \uc81c\ud488\uc774 FDA \uc2b9\uc778\uc744 \ubc1b\uc558\ub2e4\ub294 \uc758\ubbf8\ub294 \uc544\ub2d9\ub2c8\ub2e4.<\/p>\n\n<p class=\"translation-block\">\uc81c\ud488 \uad00\ub828 \uc0ac\ud56d\uc740 <a href=\"https:\/\/relish-tech.com\/kr\/%eb%ac%bc-%ec%b9%98%ec%8b%a4-oem-odm-%ea%b5%ac%eb%a7%a4%ec%9e%90-%ea%b0%80%ec%9d%b4%eb%93%9c\/\" target=\"_self\">\uad6c\uac15\uc138\uc815\uae30 OEM\/ODM \uad6c\ub9e4 \uac00\uc774\ub4dc<\/a>\ub97c \ucc38\uace0\ud558\uac70\ub098 <a href=\"https:\/\/relish-tech.com\/kr\/%ec%97%b0%eb%9d%bd%ec%b2%98\/\" target=\"_self\">Relish Tech\uc5d0 \ubb38\uc758\ud558\uc138\uc694<\/a>.<\/p>\n\n<p>\ubaa8\ub378, \uad6c\uc131 \ubc0f \uc8fc\ubb38 \uc694\uac74\uc5d0 \ub530\ub978 \uacf5\uc7a5 \uc9c1\uac70\ub798 \uac00\uaca9\uc740 Relish Tech\uc5d0 \ubb38\uc758\ud558\uc138\uc694.<\/p>\n\n<h2>\uc790\uc8fc \ubb3b\ub294 \uc9c8\ubb38<\/h2>\n\n<h3>\ubbf8\uad6d\uc5d0\uc11c \uad6c\uac15\uc138\uc815\uae30\ub294 \uc758\ub8cc\uae30\uae30\uc778\uac00\uc694?<\/h3>\n\n<p>FDA\ub294 \uad6c\uac15\uc138\uc815\uae30\ub97c \uc81c\ud488 \ucf54\ub4dc EFS\uc5d0 \ub530\ub978 Class I \uc758\ub8cc\uae30\uae30 \ubc94\uc8fc\ub85c \ub4f1\uc7ac\ud569\ub2c8\ub2e4. \uac1c\ubcc4 \ubaa8\ub378\uc774 \uc774 \ubc94\uc8fc\uc5d0 \ud574\ub2f9\ud558\ub294\uc9c0\ub294 \uc0ac\uc6a9 \ubaa9\uc801, \ud45c\uc2dc\u00b7\uad11\uace0 \ub0b4\uc6a9, \uc124\uacc4\uc5d0 \ub530\ub77c \ub2ec\ub77c\uc9d1\ub2c8\ub2e4.<\/p>\n\n<h3>FDA \ub4f1\ub85d\uc744 \ud558\uba74 \uad6c\uac15\uc138\uc815\uae30\uac00 FDA \uc2b9\uc778\uc744 \ubc1b\uc740 \uac74\uac00\uc694?<\/h3>\n\n<p>\uc544\ub2c8\uc694. \uc0ac\uc5c5\uc7a5 \ub4f1\ub85d\uacfc \uae30\uae30 \ub4f1\uc7ac\ub294 FDA\uc758 \uc2dc\ud310\ud5c8\uac00(clearance)\ub098 \uc2b9\uc778(approval)\uacfc \ub2e4\ub985\ub2c8\ub2e4. FDA\ub294 \uc758\ub8cc\uae30\uae30\uc5d0 \ub300\ud55c \uc77c\ubc18\uc801\uc778 \ub4f1\ub85d\uc99d\uba85\uc11c\ub97c \ubc1c\uae09\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/p>\n\n<h3>\ubaa8\ub4e0 \uad6c\uac15\uc138\uc815\uae30\uc5d0 510(k)\uac00 \ud544\uc694\ud55c\uac00\uc694?<\/h3>\n\n<p>\uc544\ub2c8\uc694. EFS \ubc94\uc8fc\ub294 \uc77c\ubc18\uc801\uc73c\ub85c 510(k) \uc2dc\ud310 \uc804 \uc2e0\uace0\uac00 \uba74\uc81c\ub418\uc9c0\ub9cc \uc801\uc6a9\ub418\ub294 \uc81c\ud55c\uc774 \uc788\uc2b5\ub2c8\ub2e4. \uc815\ud655\ud55c \ubaa8\ub378\uacfc \uc0ac\uc6a9 \ubaa9\uc801\uc5d0 \ub300\ud55c \uaddc\uc81c \uacbd\ub85c\ub97c \ud655\uc778\ud558\uc138\uc694.<\/p>\n\n<h3>OEM \uad6c\ub9e4\uc790\ub294 \ubb34\uc5c7\uc744 \uba3c\uc800 \ud655\uc778\ud574\uc57c \ud558\ub098\uc694?<\/h3>\n\n<p>\uc0ac\uc6a9 \ubaa9\uc801, \ubaa8\ub378 \uad6c\uc131, \ud45c\uc2dc\u00b7\uad11\uace0 \ub0b4\uc6a9, \ucc45\uc784\uc744 \ub9e1\ub294 \uc81c\uc870\uc5c5\uccb4\uc640 \uc218\uc785\uc5c5\uccb4, \ud45c\uc2dc \uc0ac\ud56d, \uc2dc\ud5d8 \uc790\ub8cc, \ub300\uc0c1 \uc2dc\uc7a5\uc5d0 \uc801\uc6a9\ub418\ub294 \uaddc\uc81c \uc808\ucc28\ub97c \ud655\uc778\ud558\uc138\uc694.<\/p>\n\n<h3>\uad6c\uac15\uc138\uc815\uae30 OEM \ud504\ub85c\uc81d\ud2b8\uc758 \ucd5c\uc18c \uc8fc\ubb38 \uc218\ub7c9(MOQ)\uc740 \uc5b4\ub290 \uc815\ub3c4\ub85c \uc608\uc0c1\ud574\uc57c \ud558\ub098\uc694?<\/h3>\n\n<p>Relish Tech\uc758 \ud45c\uc900 \ucd5c\uc18c \uc8fc\ubb38 \uc218\ub7c9(MOQ)\uc740 <strong>1,000\uac1c<\/strong>\uc785\ub2c8\ub2e4. \uc81c\ud488 \uad6c\uc131\uacfc \ud504\ub85c\uc81d\ud2b8 \uc694\uac74\uc740 \ub2f9\uc0ac \ud300\uacfc \ud611\uc758\ud574 \uc8fc\uc138\uc694.<\/p>\n\n<h2>\ucc38\uace0 \uc790\ub8cc<\/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 \uc81c\ud488 \ucf54\ub4dc EFS: \uad6c\uac15\uc138\uc815\uae30<\/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: FDA \ub4f1\ub85d \ub610\ub294 FDA \uc778\uc99d \uc758\ub8cc\uae30\uae30\uac00 \uc788\ub098\uc694?<\/a><\/li>\n<li><a href=\"https:\/\/relish-tech.com\/kr\/%ec%9d%b8%ec%a6%9d\/\">Relish Tech \uc778\uc99d \ubc0f \ud488\uc9c8 \uc815\ubcf4<\/a><\/li>\n<li><a href=\"https:\/\/relish-tech.com\/kr\/%eb%ac%bc-%ec%b9%98%ec%8b%a4-oem-odm-%ea%b5%ac%eb%a7%a4%ec%9e%90-%ea%b0%80%ec%9d%b4%eb%93%9c\/\">Relish Tech \uad6c\uac15\uc138\uc815\uae30 OEM\/ODM \uad6c\ub9e4 \uac00\uc774\ub4dc<\/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\/kr\/wp-json\/wp\/v2\/posts\/3973","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/relish-tech.com\/kr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/relish-tech.com\/kr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/relish-tech.com\/kr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/relish-tech.com\/kr\/wp-json\/wp\/v2\/comments?post=3973"}],"version-history":[{"count":5,"href":"https:\/\/relish-tech.com\/kr\/wp-json\/wp\/v2\/posts\/3973\/revisions"}],"predecessor-version":[{"id":8413,"href":"https:\/\/relish-tech.com\/kr\/wp-json\/wp\/v2\/posts\/3973\/revisions\/8413"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/relish-tech.com\/kr\/wp-json\/wp\/v2\/media\/8527"}],"wp:attachment":[{"href":"https:\/\/relish-tech.com\/kr\/wp-json\/wp\/v2\/media?parent=3973"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/relish-tech.com\/kr\/wp-json\/wp\/v2\/categories?post=3973"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/relish-tech.com\/kr\/wp-json\/wp\/v2\/tags?post=3973"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}