{"id":3973,"date":"2021-10-30T01:00:00","date_gmt":"2021-10-30T01:00:00","guid":{"rendered":"https:\/\/relish.quhenet.com\/?p=3973"},"modified":"2026-03-12T01:01:16","modified_gmt":"2026-03-12T01:01:16","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":"\uc6cc\ud130 \ud50c\ub85c\uc11c\ub294 \uc758\ub8cc \uae30\uae30\uc778\uac00\uc694?"},"content":{"rendered":"

\uccad\uc18c \ud6a8\uacfc\u00a0\ubb3c \uce58\uc2e4<\/strong>\u00a0\ub294 \uc8fc\ub85c \uc77c\uc815\ud55c \uc555\ub825 \ud558\uc5d0\uc11c \ubd84\ucd9c\ub418\ub294 \uace0\uc18d \ubb3c\uc904\uae30\uc758 \ucda9\uaca9\ub825\uc5d0 \uc758\ud574 \uc2e4\ud604\ub429\ub2c8\ub2e4. \ubb3c \ud750\ub984 \uc790\uccb4\uc758 \ucda9\uaca9\ub825\uc744 \ubc14\ud0d5\uc73c\ub85c \ub2e4\uc74c\uacfc \uac19\uc740 \uc870\uce58\ub97c \uacb0\ud569\ud558\uc5ec \uccad\uc18c \ud6a8\uacfc\ub97c \ub354\uc6b1 \ud5a5\uc0c1\uc2dc\ud0ac \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

\ubb3c \uce58\uc2e4\uae30\uac00 \uc758\ub8cc\uae30\uae30 \uae30\uc900\uc5d0 \ub530\ub77c FDA\uc758 \uc778\uc99d\uc744 \ubc1b\uc544\uc57c \ud558\ub294 \uc774\uc720\ub294 \ubb34\uc5c7\uc778\uac00\uc694?<\/h3>\n\n\n\n

\uc694\uc810 1. \uc778\uccb4\uc5d0 \uc0ac\uc6a9\ub428, 2. \ubaa9\uc801\uc740 \uc9c8\ubcd1 \uc608\ubc29, 3. \uc57d\ub9ac\ud559, \uba74\uc5ed\ud559 \ub610\ub294 \uc2e0\uc9c4\ub300\uc0ac\ub97c \ud1b5\ud574 \ud6a8\uacfc\ub97c \uc5bb\uc9c0 \ubabb\ud568. \ud544\uc694\ud55c \uc18c\ud504\ud2b8\uc6e8\uc5b4\ub97c \ud3ec\ud568\ud55c \ud56d\ubaa9; \uc778\uccb4\uc758 \ud45c\uba74\uacfc \uc2e0\uccb4\uc5d0 \ubbf8\uce58\ub294 \uc601\ud5a5\uc740 \uc57d\ub9ac\ud559, \uba74\uc5ed\ud559 \ub610\ub294 \uc2e0\uc9c4\ub300\uc0ac\ub97c \ud1b5\ud574 \uc5bb\uc9c0 \ubabb\ud558\uc9c0\ub9cc \uc774\ub7ec\ud55c \uc218\ub2e8\uc774 \ucc38\uc5ec\ud558\uc5ec \ud2b9\uc815 \ubcf4\uc870 \uc5ed\ud560\uc744 \ud560 \uc218 \uc788\uc73c\uba70 \uadf8 \uc0ac\uc6a9\uc740 \ub2e4\uc74c\uacfc \uac19\uc740 \uae30\ub300\uce58\ub97c \ub2ec\uc131\ud558\ub294 \uac83\uc744 \ubaa9\ud45c\ub85c \ud569\ub2c8\ub2e4. \ubaa9\uc801: 1. \uc9c8\ubcd1\uc758 \uc608\ubc29, \uc9c4\ub2e8, \uce58\ub8cc, \ubaa8\ub2c8\ud130\ub9c1 \ubc0f \uc644\ud654;
2. \ubd80\uc0c1 \ub610\ub294 \uc7a5\uc560\uc758 \uc9c4\ub2e8, \uce58\ub8cc, \ubaa8\ub2c8\ud130\ub9c1, \uc644\ud654 \ubc0f \ubcf4\uc0c1;
3. \ud574\ubd80\ud559\uc801 \ub610\ub294 \uc0dd\ub9ac\uc801 \uacfc\uc815\uc758 \uc5f0\uad6c, \ub300\uccb4 \ubc0f \uaddc\uc81c;
4. \uc784\uc2e0 \uad00\ub9ac. \uccad\uc18c \uae30\ub2a5\uc774 \uc788\uae30 \ub54c\ubb38\uc5d0 \uc758\ub8cc\uc6a9\uc5d0 \uc18d\ud558\ub294 \uc77c\ubc18 \uce6b\uc194\uacfc \ub9c8\ucc2c\uac00\uc9c0\ub85c FDA \uc758\ub8cc \uae30\uae30 \uad00\ub9ac \ubc94\uc704\uc5d0 \uc18d\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n

1. \ubb3c \uce58\uc2e4\uc740 FDA \uc778\uc99d\uc744 \uc2e0\uccad\ud574\uc57c \ud569\ub2c8\ub2e4.<\/h3>\n\n\n\n
\"\"<\/figure>\n\n\n\n

<\/a>
\uc774 \ubb3c \uce58\uc2e4\uc740 FDA \uc778\uc99d\uc744 \ubc1b\uc558\uc73c\uba70 FDA\uc758 1\ub4f1\uae09 \uc758\ub8cc \ub4f1\ub85d\uc5d0 \uc18d\ud569\ub2c8\ub2e4. FDA\ub294 \ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d\uc758 \uc57d\uc790\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n

2. FDA \uc778\uc99d \ubc0f \uc758\ub8cc \uae30\uae30 \ub4f1\ub85d\uc774 \ud544\uc694\ud569\ub2c8\ub2e4.<\/h3>\n\n\n\n

21CFR 20765\uc5d0 \ub530\ub974\uba74 \uc81c\uc870\uc5c5\uccb4, \uacc4\uc57d \uc81c\uc870\uc5c5\uccb4 \ubc0f \uacc4\uc57d \uba78\uade0\uae30, \uc0c1\uc5c5\uc801 \uc720\ud1b5 \uc7a5\ube44 \ubc30\uce58, \uc800\uc6b8 \uac1c\ubc1c\uc790, \uc7ac\ud3ec\uc7a5 \ub610\ub294 OEM, \uc77c\ud68c\uc6a9 \uc7a5\ube44 \uc7ac\ucc98\ub9ac\uc790, \uc7ac\uc81c\uc870\uc5c5\uccb4, \ubbf8\uad6d \uc218\ucd9c \uc7a5\ube44 \uc81c\uc870\uc5c5\uccb4\ub97c \ud3ec\ud568\ud558\uc5ec \ub4f1\ub85d\ud574\uc57c \ud558\ub294 \uc0c1\uc5c5\uc801 \ud310\ub9e4\uc6a9 \uc758\ub8cc\uae30\uae30\uc758 \uc81c\uc870, \uc900\ube44, \ubcf5\uc81c, \ud569\uc131, \uc870\ub9bd \ub610\ub294 \uac00\uacf5\uc5d0 \uc885\uc0ac\ud558\ub294 \ubaa8\ub4e0 \uc6b4\uc601\uc790\ub294 \uac80\uc0ac \ubc0f \uba74\uc81c \ub300\uc0c1\uc5d0\uc11c \uc81c\uc678\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4(\uc81c\uc870\uc5c5\uccb4\ub294 \uc81c\uc678\ub418\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4).<\/p>\n\n\n\n

3. FDA\uc758 \ub2e4\uc591\ud55c \uaddc\uc81c \ubc94\uc8fc\uc640 \uc81c\uacf5\ud574\uc57c \ud558\ub294 \uc815\ubcf4\uc5d0 \ub530\ub77c \uc81c\ud488\uc740 \ub450 \uac00\uc9c0 \ubc94\uc8fc\ub85c \ub098\ub269\ub2c8\ub2e4:<\/h3>\n\n\n\n

FDA \uc2e0\uace0\ub9cc \ud558\uace0 FDA \uc81c\ucd9c \uc815\ubcf4\ub294 \uc81c\uacf5\ud558\uc9c0 \uc54a\uc544\ub3c4 \ub429\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc774 \uce74\ud14c\uace0\ub9ac\uc5d0 \uc18d\ud558\ub294 \uc77c\ubc18\uc801\uc778 \uc774\ucee4\uba38\uc2a4 \uc81c\ud488\uc5d0\ub294 \ub2e4\uc74c\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4:<\/p>\n\n\n\n

1. \ub0c4\ube44 \ubc0f \ucef5, \uc8fc\ubc29 \uc6a9\ud488, \uc2dd\ud488 \uac00\uacf5 \uae30\uacc4 \ub4f1 \uc2dd\ud488 \uad00\ub828 \uc81c\ud488.<\/p>\n\n\n\n

2. \ube57, \uace0\ub370\uae30, \uce6b\uc194(\ube44\uc804\uae30\uc2dd) \ub4f1 \uc778\uccb4\uc640 \uc811\ucd09\ud558\ub294 \uae30\ud0c0 \ubb3c\ud488.<\/p>\n\n\n\n

3. \uc758\ub8cc\uae30\uae30\uac00 \uc544\ub2cc \ubc29\uc0ac\uc120\uc774 \ubc29\ucd9c\ub418\ub294 \uc804\uc790 \uc81c\ud488(\uc608: LED \ub7a8\ud504, LCD \ub514\uc2a4\ud50c\ub808\uc774, \uac00\uc2b5\uae30, \ud504\ub85c\uc81d\ud130(\uad11\uc6d0\uc740 LED\/LuminousLCD\/\ub808\uc774\uc800) \ub4f1)\uc740 ACC#\ub97c \uc81c\uacf5\ud558\uc9c0 \uc54a\uc544\ub3c4 \ub429\ub2c8\ub2e4.<\/p>\n\n\n\n

\"\"<\/figure>\n\n\n\n

\uc758\ub8cc \uae30\uae30 \uce74\ud14c\uace0\ub9ac<\/h3>\n\n\n\n

\ub2e4\uc74c\uacfc \uac19\uc740 \uce58\uacfc\uc6a9 \uc81c\ud488\uc758 \uacbd\uc6b0\u00a0\uc804\ub3d9 \uce6b\uc194<\/strong>es, \uc548\ub9c8\uae30, \uc548\ub9c8\uc758\uc790, \uadfc\uc2dc\uc6a9 \uc548\uacbd, \uc120\uae00\ub77c\uc2a4, \uccb4\uc628\uacc4, \ud608\uc555\uacc4, \uce58\uc2e4, \uad50\uc815 \uae30\uad6c \ub4f1 FDA \uc2e0\uace0 \uc2dc\uc5d0\ub294 FDA \uc81c\uc870\uc5c5\uccb4 \uae30\ub85d \ubc88\ud638, \uc81c\ud488 \ub4f1\ub85d \ubc88\ud638, \ucd5c\ucd08 \uc218\uc785\uc790 \ub4f1\ub85d \ubc88\ud638\uac00 \ud544\uc694\ud569\ub2c8\ub2e4. \uc801\uc678\uc120 \uc804\uc790 \uccb4\uc628\uacc4, \uc218\uc561 \ud38c\ud504 \ub4f1 \uc77c\ubd80 \uc758\ub8cc \uae30\uae30 \uc5ed\uc2dc 510K \uc81c\ud488 \uc0ac\uc804 \ud310\ub9e4 \uc2e0\uace0\ub97c \ud574\uc57c \ud569\ub2c8\ub2e4. 510(k)\uac00 \ud544\uc694\ud55c\uc9c0 \uc5ec\ubd80\ub294 FDA \uc6f9\uc0ac\uc774\ud2b8\uc5d0\uc11c \ud655\uc778\ud560 \uc218\ub3c4 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n

\uc804\ub3d9 \uce6b\uc194 \ubc0f \uad6c\uac15 \uc138\uc815\uae30 \/ \ubb3c \uce58\uc2e4 \uc804\ubb38 \uc81c\uc870\uc5c5\uccb4 \uc778 Shenzhen Relish\ub294 \ub2e4\uc591\ud55c \uc720\ud615\uc758 \uc804\ub3d9 \uce6b\uc194 \ub3c4\ub9e4 \ubc0f OEM \ub9de\ucda4\ud615 \uc11c\ube44\uc2a4\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4. Relish\uc5d0\uc11c \uacf5\uc7a5 \uac00\uaca9\uc73c\ub85c \ubb3c \uce58\uc2e4\uc744 \ub3c4\ub9e4 \ud560 \uc218\ub3c4 \uc788\uc2b5\ub2c8\ub2e4. \uc6b0\ub9ac\ub294 \ub2f9\uc2e0\uc5d0\uac8c \ub9e4\uc6b0 \uacbd\uc7c1\ub825\uc788\ub294 \uac00\uaca9\uc744 \uc81c\uacf5 \ud560 \uc218 \uc788\uc73c\uba70 \ub2f9\uc2e0\uacfc \ud568\uaed8 \uc77c\ud558\uae30\ub97c \uae30\ub300\ud569\ub2c8\ub2e4.<\/p>","protected":false},"excerpt":{"rendered":"

The cleaning effect of the\u00a0water flosser\u00a0is mainly realized by the impact force of the high-speed water column ejected under a […]<\/p>\n","protected":false},"author":1,"featured_media":3974,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[59],"tags":[],"class_list":["post-3973","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-industry-information"],"blocksy_meta":[],"_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":1,"href":"https:\/\/relish-tech.com\/kr\/wp-json\/wp\/v2\/posts\/3973\/revisions"}],"predecessor-version":[{"id":3977,"href":"https:\/\/relish-tech.com\/kr\/wp-json\/wp\/v2\/posts\/3973\/revisions\/3977"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/relish-tech.com\/kr\/wp-json\/wp\/v2\/media\/3974"}],"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}]}}