{"id":8170,"date":"2025-10-11T11:19:42","date_gmt":"2025-10-11T11:19:42","guid":{"rendered":"https:\/\/kmslaser.com\/?p=8170"},"modified":"2025-10-19T13:05:24","modified_gmt":"2025-10-19T13:05:24","slug":"%d0%b4%d0%be%d0%bb%d0%b6%d0%bd%d1%8b-%d0%bb%d0%b8-%d0%b8%d0%bc%d0%bf%d0%be%d1%80%d1%82%d0%b8%d1%80%d1%83%d0%b5%d0%bc%d1%8b%d0%b5-%d0%b0%d0%bf%d0%bf%d0%b0%d1%80%d0%b0%d1%82%d1%8b-%d1%83%d0%b4%d0%b0","status":"publish","type":"post","link":"https:\/\/kmslaser.com\/ru\/should-imported-shockwave-therapy-machines-meet-fda-requirements-or-certification\/","title":{"rendered":"\u0414\u043e\u043b\u0436\u043d\u044b \u043b\u0438 \u0438\u043c\u043f\u043e\u0440\u0442\u0438\u0440\u0443\u0435\u043c\u044b\u0435 \u0430\u043f\u043f\u0430\u0440\u0430\u0442\u044b \u0443\u0434\u0430\u0440\u043d\u043e-\u0432\u043e\u043b\u043d\u043e\u0432\u043e\u0439 \u0442\u0435\u0440\u0430\u043f\u0438\u0438 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u043e\u0432\u0430\u0442\u044c \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f\u043c \u0438\u043b\u0438 \u0441\u0435\u0440\u0442\u0438\u0444\u0438\u043a\u0430\u0446\u0438\u0438 FDA?"},"content":{"rendered":"<p><iframe data-testid=\"embed-iframe\" style=\"border-radius:12px\" src=\"https:\/\/open.spotify.com\/embed\/episode\/2PWlWN8VuBPgYV2y7pJsJp?utm_source=generator&amp;theme=0\" width=\"100%\" height=\"152\" frameborder=\"0\" allowfullscreen=\"\" allow=\"autoplay; clipboard-write; encrypted-media; fullscreen; picture-in-picture\" loading=\"lazy\"><\/iframe><\/p>\n<p style=\"float: right; margin-left: 15px; margin-bottom: 15px;\">\n  <img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/1close-up-product-photo-of-a-shockwave-machine-labe.jpg\" alt=\"\u0414\u0435\u0442\u0430\u043b\u044c \u0438\u0437 \u043d\u0435\u0440\u0436\u0430\u0432\u0435\u044e\u0449\u0435\u0439 \u0441\u0442\u0430\u043b\u0438 \u0441 \u043c\u0430\u0440\u043a\u0438\u0440\u043e\u0432\u043a\u043e\u0439 CE, ISO, FDA 510k (ID#1)\" class=\"top-image-square\">\n<\/p>\n<p>\u041a\u0430\u043a \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0438\u0442\u0435\u043b\u044c, \u044d\u043a\u0441\u043f\u043e\u0440\u0442\u0438\u0440\u0443\u044e\u0449\u0438\u0439 \u0430\u043f\u043f\u0430\u0440\u0430\u0442\u044b \u0443\u0434\u0430\u0440\u043d\u043e-\u0432\u043e\u043b\u043d\u043e\u0432\u043e\u0439 \u0442\u0435\u0440\u0430\u043f\u0438\u0438 \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u043e\u0433\u043e \u043a\u043b\u0430\u0441\u0441\u0430, \u044f \u0447\u0430\u0441\u0442\u043e \u043f\u043e\u043c\u043e\u0433\u0430\u044e \u043f\u043e\u043a\u0443\u043f\u0430\u0442\u0435\u043b\u044f\u043c \u0438\u0437 \u0421\u0428\u0410 \u043f\u043e\u0434\u0442\u0432\u0435\u0440\u0434\u0438\u0442\u044c, \u044f\u0432\u043b\u044f\u0435\u0442\u0441\u044f \u043b\u0438 \u043e\u0434\u043e\u0431\u0440\u0435\u043d\u0438\u0435 FDA \u043e\u0431\u044f\u0437\u0430\u0442\u0435\u043b\u044c\u043d\u044b\u043c. \u041c\u043d\u043e\u0433\u0438\u0435 \u0438\u043c\u043f\u043e\u0440\u0442\u0435\u0440\u044b \u043f\u043e\u043b\u0430\u0433\u0430\u044e\u0442, \u0447\u0442\u043e \u043c\u0430\u0440\u043a\u0438\u0440\u043e\u0432\u043a\u0438 CE \u0438\u043b\u0438 \u0441\u0435\u0440\u0442\u0438\u0444\u0438\u043a\u0430\u0446\u0438\u0438 ISO \u0434\u043e\u0441\u0442\u0430\u0442\u043e\u0447\u043d\u043e \u2014 \u043d\u043e \u0432 \u0421\u0428\u0410 \u044d\u0442\u043e \u043d\u0435 \u0442\u0430\u043a.<\/p>\n<p><strong>\u0414\u0430, \u0438\u043c\u043f\u043e\u0440\u0442\u0438\u0440\u0443\u0435\u043c\u044b\u0435 \u0430\u043f\u043f\u0430\u0440\u0430\u0442\u044b \u0443\u0434\u0430\u0440\u043d\u043e-\u0432\u043e\u043b\u043d\u043e\u0432\u043e\u0439 \u0442\u0435\u0440\u0430\u043f\u0438\u0438 \u0434\u043e\u043b\u0436\u043d\u044b \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u043e\u0432\u0430\u0442\u044c \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f\u043c FDA, \u043f\u0440\u0435\u0436\u0434\u0435 \u0447\u0435\u043c \u043e\u043d\u0438 \u043c\u043e\u0433\u0443\u0442 \u0431\u044b\u0442\u044c \u043f\u0440\u043e\u0434\u0430\u043d\u044b, \u0440\u0430\u0441\u043f\u0440\u043e\u0441\u0442\u0440\u0430\u043d\u0435\u043d\u044b \u0438\u043b\u0438 \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u043d\u044b \u0432 \u043a\u043b\u0438\u043d\u0438\u0447\u0435\u0441\u043a\u043e\u0439 \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0435 \u0432 \u0421\u043e\u0435\u0434\u0438\u043d\u0435\u043d\u043d\u044b\u0445 \u0428\u0442\u0430\u0442\u0430\u0445. \u0411\u043e\u043b\u044c\u0448\u0438\u043d\u0441\u0442\u0432\u043e \u043c\u043e\u0434\u0435\u043b\u0435\u0439 \u0442\u0440\u0435\u0431\u0443\u044e\u0442 \u043b\u0438\u0431\u043e \u043e\u0434\u043e\u0431\u0440\u0435\u043d\u0438\u044f \u043f\u043e \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u0435 510(k), \u043b\u0438\u0431\u043e \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u044f De Novo, \u0432 \u0437\u0430\u0432\u0438\u0441\u0438\u043c\u043e\u0441\u0442\u0438 \u043e\u0442 \u043a\u043b\u0430\u0441\u0441\u0438\u0444\u0438\u043a\u0430\u0446\u0438\u0438 \u0438 \u043f\u0440\u0435\u0434\u043f\u043e\u043b\u0430\u0433\u0430\u0435\u043c\u043e\u0433\u043e \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u043d\u0438\u044f.<\/strong><\/p>\n<p>\u041d\u0435\u0441\u043e\u0431\u043b\u044e\u0434\u0435\u043d\u0438\u0435 \u043c\u043e\u0436\u0435\u0442 \u043f\u0440\u0438\u0432\u0435\u0441\u0442\u0438 \u043a \u0437\u0430\u0434\u0435\u0440\u0436\u0430\u043d\u0438\u044e \u043d\u0430 \u0442\u0430\u043c\u043e\u0436\u043d\u0435, \u043e\u0442\u043a\u0430\u0437\u0443 \u0432\u043e \u0432\u0432\u043e\u0437\u0435 \u0438\u043b\u0438 \u043a\u043e\u043d\u0444\u0438\u0441\u043a\u0430\u0446\u0438\u0438 \u043f\u0440\u043e\u0434\u0443\u043a\u0446\u0438\u0438.<\/p>\n<hr \/>\n<h2>\u041e\u0431\u044f\u0437\u0430\u0442\u0435\u043b\u044c\u043d\u043e \u043b\u0438 \u043e\u0434\u043e\u0431\u0440\u0435\u043d\u0438\u0435 FDA \u0434\u043b\u044f \u0438\u043c\u043f\u043e\u0440\u0442\u0430?<\/h2>\n<p>\u041c\u043d\u043e\u0433\u0438\u0435 \u0438\u043c\u043f\u043e\u0440\u0442\u0435\u0440\u044b \u0443\u0434\u0438\u0432\u043b\u044f\u044e\u0442\u0441\u044f, \u0447\u0442\u043e \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0435 \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f\u043c FDA \u043f\u0440\u0438\u043c\u0435\u043d\u044f\u0435\u0442\u0441\u044f \u0435\u0449\u0435 \u0434\u043e \u0442\u043e\u0433\u043e, \u043a\u0430\u043a \u0443\u0441\u0442\u0440\u043e\u0439\u0441\u0442\u0432\u043e \u043f\u043e\u043f\u0430\u0434\u0430\u0435\u0442 \u043d\u0430 \u0440\u044b\u043d\u043e\u043a \u0421\u0428\u0410, \u0430 \u043d\u0435 \u043f\u043e\u0441\u043b\u0435.<\/p>\n<p><strong>\u0414\u0430, \u043e\u0434\u043e\u0431\u0440\u0435\u043d\u0438\u0435 FDA \u044f\u0432\u043b\u044f\u0435\u0442\u0441\u044f \u043e\u0431\u044f\u0437\u0430\u0442\u0435\u043b\u044c\u043d\u044b\u043c, \u0435\u0441\u043b\u0438 \u0443\u0441\u0442\u0440\u043e\u0439\u0441\u0442\u0432\u043e \u0431\u0443\u0434\u0435\u0442 \u043f\u0440\u043e\u0434\u0430\u0432\u0430\u0442\u044c\u0441\u044f, \u0440\u0430\u0441\u043f\u0440\u043e\u0441\u0442\u0440\u0430\u043d\u044f\u0442\u044c\u0441\u044f \u0438\u043b\u0438 \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u0442\u044c\u0441\u044f \u0432 \u0442\u0435\u0440\u0430\u043f\u0435\u0432\u0442\u0438\u0447\u0435\u0441\u043a\u0438\u0445 \u0446\u0435\u043b\u044f\u0445 \u0432 \u0421\u0428\u0410. \u0422\u043e\u043b\u044c\u043a\u043e \u043d\u0435\u0441\u043a\u043e\u043b\u044c\u043a\u043e \u043c\u043e\u0434\u0435\u043b\u0435\u0439 \u0441 \u043d\u0438\u0437\u043a\u0438\u043c \u0443\u0440\u043e\u0432\u043d\u0435\u043c \u0440\u0438\u0441\u043a\u0430 (\u043d\u0430\u043f\u0440\u0438\u043c\u0435\u0440, \u043e\u0431\u0449\u0438\u0435 \u043c\u0430\u0441\u0441\u0430\u0436\u043d\u044b\u0435 \u0443\u0441\u0442\u0440\u043e\u0439\u0441\u0442\u0432\u0430) \u043e\u0441\u0432\u043e\u0431\u043e\u0436\u0434\u0430\u044e\u0442\u0441\u044f \u043e\u0442 \u044d\u0442\u043e\u0433\u043e.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/2a-u-s-customs-inspection-area-where-officers-revi.jpg\" alt=\"\u0422\u0430\u043c\u043e\u0436\u0435\u043d\u043d\u0438\u043a\u0438 \u0434\u043e\u0441\u043c\u0430\u0442\u0440\u0438\u0432\u0430\u044e\u0442 \u043f\u0430\u0440\u0442\u0438\u044e \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u043e\u0433\u043e \u043e\u0431\u043e\u0440\u0443\u0434\u043e\u0432\u0430\u043d\u0438\u044f \u043d\u0430 \u0441\u043a\u043b\u0430\u0434\u0435 (ID#2)\" title=\"\u0422\u0430\u043c\u043e\u0436\u0435\u043d\u043d\u044b\u0439 \u0434\u043e\u0441\u043c\u043e\u0442\u0440\" \/><\/p>\n<p>\u0414\u043b\u044f \u043f\u0443\u0442\u0435\u0439 \u043f\u043e\u043b\u0443\u0447\u0435\u043d\u0438\u044f \u043e\u0434\u043e\u0431\u0440\u0435\u043d\u0438\u044f \u0438 \u043a\u043b\u0430\u0441\u0441\u043e\u0432 \u0440\u0438\u0441\u043a\u0430 \u0441\u043c. <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/classify-your-medical-device\">\u0421\u0438\u0441\u0442\u0435\u043c\u0430 \u043a\u043b\u0430\u0441\u0441\u0438\u0444\u0438\u043a\u0430\u0446\u0438\u0438 \u0443\u0441\u0442\u0440\u043e\u0439\u0441\u0442\u0432 FDA<\/a><\/strong> <sup><a href=\"#footnote-1\" id=\"ref-1\">1<\/a><\/sup>.<br \/>\n\u0418\u043c\u043f\u043e\u0440\u0442\u0435\u0440\u0430\u043c \u0442\u0430\u043a\u0436\u0435 \u0441\u043b\u0435\u0434\u0443\u0435\u0442 \u043e\u0437\u043d\u0430\u043a\u043e\u043c\u0438\u0442\u044c\u0441\u044f \u0441 <strong><a href=\"https:\/\/www.fda.gov\/industry\/import-basics\/medical-devices\">\u041e\u0441\u043d\u043e\u0432\u044b \u0438\u043c\u043f\u043e\u0440\u0442\u0430 \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u0438\u0445 \u0443\u0441\u0442\u0440\u043e\u0439\u0441\u0442\u0432 FDA<\/a><\/strong> <sup><a href=\"#footnote-2\" id=\"ref-2\">2<\/a><\/sup> \u0447\u0442\u043e\u0431\u044b \u043f\u043e\u043d\u044f\u0442\u044c \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f \u043a \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u0430\u0446\u0438\u0438 \u0438 \u0442\u0430\u043c\u043e\u0436\u0435\u043d\u043d\u044b\u0439 \u043a\u043e\u043d\u0442\u0440\u043e\u043b\u044c.<\/p>\n<h3>\u041e\u0431\u0437\u043e\u0440 \u043a\u043b\u0430\u0441\u0441\u0438\u0444\u0438\u043a\u0430\u0446\u0438\u0439 FDA<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u041f\u0440\u0435\u0434\u043f\u043e\u043b\u0430\u0433\u0430\u0435\u043c\u043e\u0435 \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u043d\u0438\u0435 \/ \u0422\u0438\u043f \u043c\u043e\u0434\u0435\u043b\u0438<\/th>\n<th>\u041a\u043b\u0430\u0441\u0441 FDA<\/th>\n<th>\u0422\u0438\u043f \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u044f<\/th>\n<th>\u041f\u0440\u0438\u043c\u0435\u0440 \u043a\u043e\u0434\u0430 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0430<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u0422\u0435\u0440\u0430\u043f\u0438\u044f \u043e\u043f\u043e\u0440\u043d\u043e-\u0434\u0432\u0438\u0433\u0430\u0442\u0435\u043b\u044c\u043d\u043e\u0433\u043e \u0430\u043f\u043f\u0430\u0440\u0430\u0442\u0430 (\u043d\u0430\u043f\u0440\u0438\u043c\u0435\u0440, \u0442\u0435\u043d\u0434\u0438\u043d\u043e\u043f\u0430\u0442\u0438\u044f, \u043e\u0431\u043b\u0435\u0433\u0447\u0435\u043d\u0438\u0435 \u0431\u043e\u043b\u0438)<\/td>\n<td>\u041a\u043b\u0430\u0441\u0441 II<\/td>\n<td>510(k)<\/td>\n<td><strong>NPV<\/strong>, <strong>ISA<\/strong><\/td>\n<\/tr>\n<tr>\n<td>\u0422\u0435\u0440\u0430\u043f\u0438\u044f \u0445\u0440\u043e\u043d\u0438\u0447\u0435\u0441\u043a\u0438\u0445 \u0440\u0430\u043d<\/td>\n<td>\u041a\u043b\u0430\u0441\u0441 II<\/td>\n<td>510(k)<\/td>\n<td><strong>PZL<\/strong><\/td>\n<\/tr>\n<tr>\n<td>\u041b\u0438\u0442\u043e\u0442\u0440\u0438\u043f\u0441\u0438\u044f (\u0434\u0440\u043e\u0431\u043b\u0435\u043d\u0438\u0435 \u043a\u0430\u043c\u043d\u0435\u0439 \u0432 \u043f\u043e\u0447\u043a\u0430\u0445)<\/td>\n<td>\u041a\u043b\u0430\u0441\u0441 III<\/td>\n<td>PMA<\/td>\n<td><strong>78F<\/strong>, <strong>LITH<\/strong><\/td>\n<\/tr>\n<tr>\n<td>\u041d\u0438\u0437\u043a\u043e\u044d\u043d\u0435\u0440\u0433\u0435\u0442\u0438\u0447\u0435\u0441\u043a\u0430\u044f \u0432\u0438\u0431\u0440\u0430\u0446\u0438\u044f \u0438\u043b\u0438 \u043c\u0430\u0441\u0441\u0430\u0436 (\u043d\u0435\u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u0438\u0435 \u043f\u043e\u043a\u0430\u0437\u0430\u043d\u0438\u044f)<\/td>\n<td>\u041a\u043b\u0430\u0441\u0441 I<\/td>\n<td>\u041e\u0441\u0432\u043e\u0431\u043e\u0436\u0434\u0435\u043d\u043e (\u043e\u0431\u0449\u0435\u0435 \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u043d\u0438\u0435)<\/td>\n<td><strong>890.5660<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>\u0427\u0442\u043e \u043f\u0440\u043e\u0438\u0441\u0445\u043e\u0434\u0438\u0442 \u0431\u0435\u0437 \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u044f FDA<\/h3>\n<p>\u0415\u0441\u043b\u0438 \u0438\u043c\u043f\u043e\u0440\u0442\u0438\u0440\u0443\u0435\u043c\u043e\u0435 \u0443\u0441\u0442\u0440\u043e\u0439\u0441\u0442\u0432\u043e \u043f\u043e\u0441\u0442\u0443\u043f\u0430\u0435\u0442 \u0431\u0435\u0437 \u0434\u0435\u0439\u0441\u0442\u0432\u0443\u044e\u0449\u0435\u0433\u043e \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u044f 510(k) \u0438\u043b\u0438 \u043e\u0441\u0432\u043e\u0431\u043e\u0436\u0434\u0435\u043d\u0438\u044f, \u0422\u0430\u043c\u043e\u0436\u0435\u043d\u043d\u0430\u044f \u0441\u043b\u0443\u0436\u0431\u0430 \u0421\u0428\u0410 \u0438 FDA \u043c\u043e\u0433\u0443\u0442:<\/p>\n<ul>\n<li><strong>\u0417\u0430\u0434\u0435\u0440\u0436\u0430\u0442\u044c \u0433\u0440\u0443\u0437<\/strong> \u0432 \u043f\u043e\u0440\u0442\u0443 (\u0441\u043c. <a href=\"https:\/\/www.accessdata.fda.gov\/cms_ia\/default.cfm\">\u0418\u043c\u043f\u043e\u0440\u0442\u043d\u044b\u0435 \u043f\u0440\u0435\u0434\u0443\u043f\u0440\u0435\u0436\u0434\u0435\u043d\u0438\u044f<\/a>) <sup><a href=\"#footnote-3\" id=\"ref-3\">3<\/a><\/sup>.  <\/li>\n<li><strong>\u041e\u0442\u043a\u0430\u0437\u0430\u0442\u044c \u0432\u043e \u0432\u0432\u043e\u0437\u0435 \u0438\u043b\u0438 \u0443\u043d\u0438\u0447\u0442\u043e\u0436\u0438\u0442\u044c<\/strong> \u0443\u0441\u0442\u0440\u043e\u0439\u0441\u0442\u0432\u043e.  <\/li>\n<li><strong>\u0412\u043d\u0435\u0441\u0442\u0438 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0438\u0442\u0435\u043b\u044f \u0438\u043b\u0438 \u0438\u043c\u043f\u043e\u0440\u0442\u0435\u0440\u0430 \u0432 \u0447\u0435\u0440\u043d\u044b\u0439 \u0441\u043f\u0438\u0441\u043e\u043a<\/strong> \u0434\u043b\u044f \u0431\u0443\u0434\u0443\u0449\u0438\u0445 \u0438\u043c\u043f\u043e\u0440\u0442\u043d\u044b\u0445 \u043f\u043e\u0441\u0442\u0430\u0432\u043e\u043a.<\/li>\n<\/ul>\n<p>\u0414\u0430\u0436\u0435 \u0434\u0435\u043c\u043e\u043d\u0441\u0442\u0440\u0430\u0446\u0438\u043e\u043d\u043d\u044b\u0435 \u0443\u0441\u0442\u0440\u043e\u0439\u0441\u0442\u0432\u0430 \u0438\u043b\u0438 \u043e\u0431\u0440\u0430\u0437\u0446\u044b \u0434\u043e\u043b\u0436\u043d\u044b \u0441\u043e\u043f\u0440\u043e\u0432\u043e\u0436\u0434\u0430\u0442\u044c\u0441\u044f \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u0430\u0446\u0438\u0435\u0439, \u0443\u043a\u0430\u0437\u044b\u0432\u0430\u044e\u0449\u0435\u0439 \u043d\u0430 \u043d\u0435\u043a\u043b\u0438\u043d\u0438\u0447\u0435\u0441\u043a\u043e\u0435 \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u043d\u0438\u0435 (\u043d\u0430\u043f\u0440\u0438\u043c\u0435\u0440, \u201c\u0442\u043e\u043b\u044c\u043a\u043e \u0434\u043b\u044f \u0432\u044b\u0441\u0442\u0430\u0432\u043a\u0438\u201d).<\/p>\n<hr \/>\n<h2>\u041a\u0430\u043a \u043f\u0440\u043e\u0432\u0435\u0440\u0438\u0442\u044c \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0435 \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f\u043c FDA<\/h2>\n<p>\u041f\u043e\u043a\u0443\u043f\u0430\u0442\u0435\u043b\u0438 \u0432\u0441\u0435\u0433\u0434\u0430 \u0434\u043e\u043b\u0436\u043d\u044b \u0443\u0431\u0435\u0434\u0438\u0442\u044c\u0441\u044f, \u0447\u0442\u043e \u043c\u043e\u0434\u0435\u043b\u044c \u043f\u043e\u0441\u0442\u0430\u0432\u0449\u0438\u043a\u0430 \u043f\u043e\u043b\u0443\u0447\u0438\u043b\u0430 \u043e\u0434\u043e\u0431\u0440\u0435\u043d\u0438\u0435 FDA \u043f\u0435\u0440\u0435\u0434 \u043f\u043e\u043a\u0443\u043f\u043a\u043e\u0439. \u042d\u0442\u043e \u043c\u043e\u0436\u043d\u043e \u043f\u0440\u043e\u0432\u0435\u0440\u0438\u0442\u044c \u043f\u0443\u0431\u043b\u0438\u0447\u043d\u043e.<\/p>\n<p><strong>\u0412\u044b \u043c\u043e\u0436\u0435\u0442\u0435 \u043f\u0440\u043e\u0432\u0435\u0440\u0438\u0442\u044c \u043e\u0434\u043e\u0431\u0440\u0435\u043d\u0438\u0435 FDA, \u043f\u0440\u043e\u0432\u0435\u0440\u0438\u0432 \u043e\u0444\u0438\u0446\u0438\u0430\u043b\u044c\u043d\u0443\u044e <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm\">\u0431\u0430\u0437\u0443 \u0434\u0430\u043d\u043d\u044b\u0445 FDA 510(k)<\/a><\/strong> <sup><a href=\"#footnote-4\" id=\"ref-4\">4<\/a><\/sup><br \/>\n\u0438\u043b\u0438 <strong><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfRL\/rl.cfm\">\u0431\u0430\u0437\u0443 \u0434\u0430\u043d\u043d\u044b\u0445 \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u0438 \u043f\u0440\u0435\u0434\u043f\u0440\u0438\u044f\u0442\u0438\u0439 \u0438 \u043f\u0435\u0440\u0435\u0447\u043d\u044f \u0443\u0441\u0442\u0440\u043e\u0439\u0441\u0442\u0432<\/a><\/strong> <sup><a href=\"#footnote-5\" id=\"ref-5\">5<\/a><\/sup>.<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/3a-professional-compliance-officer-reviews-fda-510-.jpg\" alt=\"\u041f\u0440\u0435\u0434\u0441\u0442\u0430\u0432\u0438\u0442\u0435\u043b\u044c \u0440\u0435\u0433\u0443\u043b\u0438\u0440\u0443\u044e\u0449\u0435\u0433\u043e \u043e\u0440\u0433\u0430\u043d\u0430 \u0440\u0430\u0441\u0441\u043c\u0430\u0442\u0440\u0438\u0432\u0430\u0435\u0442 \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u044b \u0437\u0430\u044f\u0432\u043a\u0438 FDA (ID#3)\" title=\"\u041f\u0440\u043e\u0446\u0435\u0441\u0441 \u0440\u0430\u0441\u0441\u043c\u043e\u0442\u0440\u0435\u043d\u0438\u044f FDA\" \/><\/p>\n<p>\u0415\u0441\u043b\u0438 \u043c\u043e\u0434\u0435\u043b\u044c \u043d\u0435 \u0438\u043c\u0435\u0435\u0442 \u043f\u0440\u0435\u0434\u0438\u043a\u0430\u0442\u043d\u043e\u0433\u043e \u0443\u0441\u0442\u0440\u043e\u0439\u0441\u0442\u0432\u0430, \u043c\u043e\u0436\u0435\u0442 \u043f\u043e\u0442\u0440\u0435\u0431\u043e\u0432\u0430\u0442\u044c\u0441\u044f <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/selecting-de-novo-direct-class-ii-route-de-novo-classification\">\u043a\u043b\u0430\u0441\u0441\u0438\u0444\u0438\u043a\u0430\u0446\u0438\u044f De Novo<\/a><\/strong> <sup><a href=\"#footnote-6\" id=\"ref-6\">6<\/a><\/sup> \u0432\u043c\u0435\u0441\u0442\u043e \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u043d\u043e\u0433\u043e 510(k).<\/p>\n<h3>\u041a\u043e\u043d\u0442\u0440\u043e\u043b\u044c\u043d\u044b\u0439 \u0441\u043f\u0438\u0441\u043e\u043a \u0434\u043b\u044f \u043f\u0440\u043e\u0432\u0435\u0440\u043a\u0438<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u0428\u0430\u0433<\/th>\n<th>\u0427\u0442\u043e \u043f\u0440\u043e\u0432\u0435\u0440\u0438\u0442\u044c<\/th>\n<th>\u041f\u0440\u0438\u043c\u0435\u0440 \u0437\u0430\u043f\u0438\u0441\u0438<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>1<\/td>\n<td>\u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u043e\u043d\u043d\u044b\u0439 \u043d\u043e\u043c\u0435\u0440 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0438\u0442\u0435\u043b\u044f \u0432 FDA<\/td>\n<td>\u043d\u0430\u043f\u0440\u0438\u043c\u0435\u0440, 3012345678<\/td>\n<\/tr>\n<tr>\n<td>2<\/td>\n<td>\u041f\u0435\u0440\u0435\u0447\u0435\u043d\u044c \u0443\u0441\u0442\u0440\u043e\u0439\u0441\u0442\u0432 \u0441 \u043f\u0440\u0430\u0432\u0438\u043b\u044c\u043d\u044b\u043c \u043a\u043e\u0434\u043e\u043c \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0430<\/td>\n<td>\u201cPZL \u2013 \u0423\u0441\u0442\u0440\u043e\u0439\u0441\u0442\u0432\u043e, \u0443\u0434\u0430\u0440\u043d\u043e-\u0432\u043e\u043b\u043d\u043e\u0432\u043e\u0435, \u0434\u043b\u044f \u0437\u0430\u0436\u0438\u0432\u043b\u0435\u043d\u0438\u044f \u0440\u0430\u043d\u201d<\/td>\n<\/tr>\n<tr>\n<td>3<\/td>\n<td>\u041d\u043e\u043c\u0435\u0440 510(k) \u0438 \u0434\u0430\u0442\u0430 \u043f\u0440\u0438\u043d\u044f\u0442\u0438\u044f \u0440\u0435\u0448\u0435\u043d\u0438\u044f<\/td>\n<td>\u043d\u0430\u043f\u0440\u0438\u043c\u0435\u0440, <strong>K202112<\/strong> (\u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u043e \u0432 2021 \u0433.)<\/td>\n<\/tr>\n<tr>\n<td>4<\/td>\n<td>\u0423\u043a\u0430\u0437\u0430\u043d \u0430\u043c\u0435\u0440\u0438\u043a\u0430\u043d\u0441\u043a\u0438\u0439 \u043f\u0440\u0435\u0434\u0441\u0442\u0430\u0432\u0438\u0442\u0435\u043b\u044c \u0438\u043b\u0438 \u0438\u043c\u043f\u043e\u0440\u0442\u0435\u0440<\/td>\n<td>\u0417\u0430\u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0438\u0440\u043e\u0432\u0430\u043d\u043e \u043f\u043e\u0434 \u0442\u0435\u043c \u0436\u0435 \u043d\u0430\u0437\u0432\u0430\u043d\u0438\u0435\u043c \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0438\u0442\u0435\u043b\u044f<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>\u0422\u0440\u0435\u0432\u043e\u0436\u043d\u044b\u0435 \u0441\u0438\u0433\u043d\u0430\u043b\u044b<\/h3>\n<ul>\n<li>\u041f\u043e\u0441\u0442\u0430\u0432\u0449\u0438\u043a \u043f\u0440\u0435\u0434\u043e\u0441\u0442\u0430\u0432\u043b\u044f\u0435\u0442 \u0442\u043e\u043b\u044c\u043a\u043e \u201c\u0441\u0435\u0440\u0442\u0438\u0444\u0438\u043a\u0430\u0442 CE\u201d.\u201d  <\/li>\n<li>\u041d\u043e\u043c\u0435\u0440 FDA \u043d\u0435 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0443\u0435\u0442 \u043d\u0430\u0437\u0432\u0430\u043d\u0438\u044e \u043a\u043e\u043c\u043f\u0430\u043d\u0438\u0438.  <\/li>\n<li>\u0417\u0430\u044f\u0432\u043b\u044f\u0435\u0442 \u201c\u0437\u0430\u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0438\u0440\u043e\u0432\u0430\u043d\u043e FDA\u201d \u0431\u0435\u0437 \u043f\u043e\u0434\u0442\u0432\u0435\u0440\u0436\u0434\u0435\u043d\u0438\u044f \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u044f.<\/li>\n<\/ul>\n<p>\u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044f \u2260 \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u0435. \u0422\u043e\u043b\u044c\u043a\u043e \u043e\u0444\u0438\u0446\u0438\u0430\u043b\u044c\u043d\u043e\u0435 \u043f\u0438\u0441\u044c\u043c\u043e 510(k) \u043f\u043e\u0434\u0442\u0432\u0435\u0440\u0436\u0434\u0430\u0435\u0442 \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u0435 \u043d\u0430 \u043c\u0430\u0440\u043a\u0435\u0442\u0438\u043d\u0433 \u0432 \u0421\u0428\u0410.<\/p>\n<hr \/>\n<h2>\u041a\u0430\u043a\u0438\u0435 \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u044b \u043f\u043e\u0434\u0442\u0432\u0435\u0440\u0436\u0434\u0430\u044e\u0442 \u043e\u0434\u043e\u0431\u0440\u0435\u043d\u0438\u0435 FDA?<\/h2>\n<p>\u041f\u043e \u043c\u043e\u0435\u043c\u0443 \u043e\u043f\u044b\u0442\u0443, \u043f\u043e\u043a\u0443\u043f\u0430\u0442\u0435\u043b\u0438 \u0434\u043e\u043b\u0436\u043d\u044b \u0437\u0430\u043f\u0440\u0430\u0448\u0438\u0432\u0430\u0442\u044c \u0441\u043b\u0435\u0434\u0443\u044e\u0449\u0443\u044e \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u0430\u0446\u0438\u044e \u0434\u043b\u044f \u043f\u0440\u043e\u0432\u0435\u0440\u043a\u0438 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u044f \u043f\u0435\u0440\u0435\u0434 \u043e\u0442\u0433\u0440\u0443\u0437\u043a\u043e\u0439.<\/p>\n<p><strong>\u0414\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u044b, \u043f\u043e\u0434\u0442\u0432\u0435\u0440\u0436\u0434\u0430\u044e\u0449\u0438\u0435 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0435 \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f\u043c FDA, \u0432\u043a\u043b\u044e\u0447\u0430\u044e\u0442 \u043f\u0438\u0441\u044c\u043c\u043e \u043e \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u0438 510(k), \u0437\u0430\u043f\u0438\u0441\u044c \u043e \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u0438 \u0443\u0441\u0442\u0440\u043e\u0439\u0441\u0442\u0432\u0430, \u0441\u0435\u0440\u0442\u0438\u0444\u0438\u043a\u0430\u0442 \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u0438 \u043f\u0440\u0435\u0434\u043f\u0440\u0438\u044f\u0442\u0438\u044f \u0438 \u043c\u0430\u0440\u043a\u0438\u0440\u043e\u0432\u043a\u0443, \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0443\u044e\u0449\u0443\u044e \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u043d\u044b\u043c \u043f\u043e\u043a\u0430\u0437\u0430\u043d\u0438\u044f\u043c.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/4close-up-of-an-official-fda-510-k-clearance-lette.jpg\" alt=\"\u041f\u043e\u0434\u043f\u0438\u0441\u0430\u043d\u043d\u044b\u0439 \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442 \u043e \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u0438 FDA 510(k) \u043d\u0430 \u0441\u0442\u043e\u043b\u0435 (ID#4)\" title=\"\u041e\u0434\u043e\u0431\u0440\u0435\u043d\u0438\u0435 510k\" \/><\/p>\n<p>\u041f\u043e\u043a\u0443\u043f\u0430\u0442\u0435\u043b\u0438 \u0438\u0437 \u0421\u0428\u0410 \u0442\u0430\u043a\u0436\u0435 \u0434\u043e\u043b\u0436\u043d\u044b \u043e\u0431\u0435\u0441\u043f\u0435\u0447\u0438\u0442\u044c \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0435 <strong><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-820\">\u041f\u0440\u0430\u0432\u0438\u043b\u0430\u043c \u0441\u0438\u0441\u0442\u0435\u043c\u044b \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u0430 21 CFR, \u0447\u0430\u0441\u0442\u044c 820<\/a><\/strong> <sup><a href=\"#footnote-7\" id=\"ref-7\">7<\/a><\/sup> \u0438<br \/>\n<strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/labeling-requirements\">\u0422\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f\u043c FDA \u043a \u043c\u0430\u0440\u043a\u0438\u0440\u043e\u0432\u043a\u0435 \u0443\u0441\u0442\u0440\u043e\u0439\u0441\u0442\u0432<\/a><\/strong> <sup><a href=\"#footnote-8\" id=\"ref-8\">8<\/a><\/sup>.<\/p>\n<h3>\u0421\u043f\u0438\u0441\u043e\u043a \u043e\u0441\u043d\u043e\u0432\u043d\u044b\u0445 \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u043e\u0432 FDA<\/h3>\n<table>\n<thead>\n<tr>\n<th>\u041d\u0430\u0437\u0432\u0430\u043d\u0438\u0435 \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u0430<\/th>\n<th>\u0426\u0435\u043b\u044c \/ \u041f\u0440\u043e\u0432\u0435\u0440\u043e\u0447\u043d\u043e\u0435 \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u043d\u0438\u0435<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>\u041f\u0438\u0441\u044c\u043c\u043e \u043e \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u0438 FDA 510(k)<\/strong><\/td>\n<td>\u041e\u0444\u0438\u0446\u0438\u0430\u043b\u044c\u043d\u043e\u0435 \u043f\u043e\u0434\u0442\u0432\u0435\u0440\u0436\u0434\u0435\u043d\u0438\u0435 \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u044f \u043d\u0430 \u0432\u044b\u0445\u043e\u0434 \u043d\u0430 \u0440\u044b\u043d\u043e\u043a.<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0417\u0430\u043f\u0438\u0441\u044c \u043e \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u0438 \u0443\u0441\u0442\u0440\u043e\u0439\u0441\u0442\u0432\u0430<\/strong><\/td>\n<td>\u0423\u043a\u0430\u0437\u044b\u0432\u0430\u0435\u0442 \u043d\u0430\u0437\u0432\u0430\u043d\u0438\u0435 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u0430, \u043a\u043b\u0430\u0441\u0441 \u0438 \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044e \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0438\u0442\u0435\u043b\u044f.<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0420\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044f \u043f\u0440\u0435\u0434\u043f\u0440\u0438\u044f\u0442\u0438\u044f<\/strong><\/td>\n<td>\u041f\u043e\u0434\u0442\u0432\u0435\u0440\u0436\u0434\u0430\u0435\u0442 \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u044e \u0438\u043d\u043e\u0441\u0442\u0440\u0430\u043d\u043d\u043e\u0439 \u0444\u0430\u0431\u0440\u0438\u043a\u0438 \u0438 \u0430\u0433\u0435\u043d\u0442\u0430 \u0432 \u0421\u0428\u0410.<\/td>\n<\/tr>\n<tr>\n<td><strong>\u041b\u0438\u0441\u0442 \u0441 \u043c\u0430\u0440\u043a\u0438\u0440\u043e\u0432\u043a\u043e\u0439 \u0438 \u043f\u043e\u043a\u0430\u0437\u0430\u043d\u0438\u044f\u043c\u0438<\/strong><\/td>\n<td>\u0414\u043e\u043b\u0436\u0435\u043d \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u043e\u0432\u0430\u0442\u044c \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u043d\u043e\u043c\u0443 FDA \u043d\u0430\u0437\u043d\u0430\u0447\u0435\u043d\u0438\u044e.<\/td>\n<\/tr>\n<tr>\n<td><strong>\u0421\u0435\u0440\u0442\u0438\u0444\u0438\u043a\u0430\u0442 \u0441\u0438\u0441\u0442\u0435\u043c\u044b \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u0430 (21 CFR 820)<\/strong><\/td>\n<td>\u041f\u043e\u0434\u0442\u0432\u0435\u0440\u0436\u0434\u0430\u0435\u0442 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0435 \u043f\u0440\u043e\u0438\u0437\u0432\u043e\u0434\u0441\u0442\u0432\u0435\u043d\u043d\u044b\u043c \u0441\u0442\u0430\u043d\u0434\u0430\u0440\u0442\u0430\u043c.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3>\u0420\u0430\u0441\u043f\u0440\u043e\u0441\u0442\u0440\u0430\u043d\u0435\u043d\u043d\u044b\u0435 \u0437\u0430\u0431\u043b\u0443\u0436\u0434\u0435\u043d\u0438\u044f<\/h3>\n<ul>\n<li>\u041a\u043e\u043c\u043f\u0430\u043d\u0438\u044f \u043c\u043e\u0436\u0435\u0442 \u0431\u044b\u0442\u044c \u201c\u0437\u0430\u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0438\u0440\u043e\u0432\u0430\u043d\u0430 FDA\u201d \u0431\u0435\u0437 <strong>\u0443\u0441\u0442\u0440\u043e\u0439\u0441\u0442\u0432\u043e<\/strong> \u043f\u043e\u043b\u0443\u0447\u0435\u043d\u0438\u044f \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u044f.  <\/li>\n<li>CE \u0438\u043b\u0438 ISO 13485 <strong>\u043d\u0435 \u044f\u0432\u043b\u044f\u044e\u0442\u0441\u044f \u0437\u0430\u043c\u0435\u043d\u043e\u0439<\/strong> \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u044f FDA.  <\/li>\n<li>\u041a\u0430\u0436\u0434\u0430\u044f \u043c\u043e\u0434\u0435\u043b\u044c \u0442\u0440\u0435\u0431\u0443\u0435\u0442 \u0441\u0432\u043e\u0435\u0433\u043e \u0441\u043e\u0431\u0441\u0442\u0432\u0435\u043d\u043d\u043e\u0433\u043e \u043d\u043e\u043c\u0435\u0440\u0430 510(k).<\/li>\n<\/ul>\n<p>\u041f\u043e\u0434\u0440\u043e\u0431\u043d\u0435\u0435 \u043e \u0440\u043e\u043b\u044f\u0445 \u0438\u043c\u043f\u043e\u0440\u0442\u0435\u0440\u0430 \u043c\u043e\u0436\u043d\u043e \u0443\u0437\u043d\u0430\u0442\u044c \u0432 <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/overview-device-regulation\/establishment-registration-medical-devices\">\u0440\u0443\u043a\u043e\u0432\u043e\u0434\u0441\u0442\u0432\u0435 FDA \u043f\u043e \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u0438 \u043f\u0440\u0435\u0434\u043f\u0440\u0438\u044f\u0442\u0438\u0439<\/a><\/strong> <sup><a href=\"#footnote-9\" id=\"ref-9\">9<\/a><\/sup>.<\/p>\n<hr \/>\n<h2>\u0420\u0430\u0441\u043f\u0440\u043e\u0441\u0442\u0440\u0430\u043d\u044f\u044e\u0442\u0441\u044f \u043b\u0438 \u043f\u0440\u0430\u0432\u0438\u043b\u0430 FDA \u043d\u0430 \u0432\u0441\u0435 \u043c\u043e\u0434\u0435\u043b\u0438?<\/h2>\n<p>\u041d\u0435 \u0432\u0441\u0435 \u0443\u0434\u0430\u0440\u043d\u043e-\u0432\u043e\u043b\u043d\u043e\u0432\u044b\u0435 \u0441\u0438\u0441\u0442\u0435\u043c\u044b \u0440\u0435\u0433\u0443\u043b\u0438\u0440\u0443\u044e\u0442\u0441\u044f \u043e\u0434\u0438\u043d\u0430\u043a\u043e\u0432\u043e. \u041a\u043b\u0430\u0441\u0441\u0438\u0444\u0438\u043a\u0430\u0446\u0438\u044f \u0437\u0430\u0432\u0438\u0441\u0438\u0442 \u043e\u0442 <strong>\u043f\u0440\u0435\u0434\u043f\u043e\u043b\u0430\u0433\u0430\u0435\u043c\u043e\u0433\u043e \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u043e\u0433\u043e \u043f\u0440\u0438\u043c\u0435\u043d\u0435\u043d\u0438\u044f<\/strong>, <strong>\u0443\u0440\u043e\u0432\u043d\u044f \u044d\u043d\u0435\u0440\u0433\u0438\u0438<\/strong>, \u0438 <strong>\u043c\u0430\u0440\u043a\u0435\u0442\u0438\u043d\u0433\u043e\u0432\u044b\u0435 \u0437\u0430\u044f\u0432\u043b\u0435\u043d\u0438\u044f<\/strong>.<\/p>\n<p><strong>\u0414\u0430, \u0432\u0441\u0435 \u043c\u043e\u0434\u0435\u043b\u0438, \u043f\u0440\u043e\u0434\u0430\u0432\u0430\u0435\u043c\u044b\u0435 \u0438\u043b\u0438 \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u0443\u0435\u043c\u044b\u0435 \u0432 \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u0438\u0445 \u0446\u0435\u043b\u044f\u0445 \u0432 \u0421\u0428\u0410, \u043f\u043e\u0434\u043f\u0430\u0434\u0430\u044e\u0442 \u043f\u043e\u0434 \u0434\u0435\u0439\u0441\u0442\u0432\u0438\u0435 \u043f\u0440\u0430\u0432\u0438\u043b FDA, \u043d\u043e \u043d\u0438\u0437\u043a\u043e\u044d\u043d\u0435\u0440\u0433\u0435\u0442\u0438\u0447\u0435\u0441\u043a\u0438\u0435 \u043c\u043e\u0434\u0435\u043b\u0438 \u201c\u043c\u0430\u0441\u0441\u0430\u0436\u0430\u201d \u043c\u043e\u0433\u0443\u0442 \u0431\u044b\u0442\u044c \u043e\u0441\u0432\u043e\u0431\u043e\u0436\u0434\u0435\u043d\u044b, \u0435\u0441\u043b\u0438 \u043d\u0435 \u0434\u0435\u043b\u0430\u044e\u0442\u0441\u044f \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u0438\u0435 \u0437\u0430\u044f\u0432\u043b\u0435\u043d\u0438\u044f.<\/strong><\/p>\n<p><img decoding=\"async\" src=\"https:\/\/kmslaser.com\/wp-content\/uploads\/2025\/10\/5illustration-showing-four-types-of-shockwave-machi.jpg\" alt=\"\u0420\u044f\u0434 \u0430\u043f\u043f\u0430\u0440\u0430\u0442\u043e\u0432 \u0443\u0434\u0430\u0440\u043d\u043e-\u0432\u043e\u043b\u043d\u043e\u0432\u043e\u0439 \u0442\u0435\u0440\u0430\u043f\u0438\u0438 \u0441 \u0443\u043a\u0430\u0437\u0430\u043d\u0438\u0435\u043c \u043d\u0430\u0437\u043d\u0430\u0447\u0435\u043d\u0438\u044f (ID#5)\" title=\"\u041b\u0438\u043d\u0435\u0439\u043a\u0430 \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u043e\u0432 \u0443\u0434\u0430\u0440\u043d\u043e-\u0432\u043e\u043b\u043d\u043e\u0432\u043e\u0439 \u0442\u0435\u0440\u0430\u043f\u0438\u0438\" \/><\/p>\n<p>\u0421\u043f\u0438\u0441\u043a\u0438 \u0438\u0441\u043a\u043b\u044e\u0447\u0435\u043d\u0438\u0439 \u0441\u043c. \u0432 <strong><a href=\"https:\/\/www.fda.gov\/medical-devices\/premarket-submissions\/510k-exempt-devices\">\u041a\u0430\u0442\u0430\u043b\u043e\u0433\u0435 \u0443\u0441\u0442\u0440\u043e\u0439\u0441\u0442\u0432 FDA, \u043e\u0441\u0432\u043e\u0431\u043e\u0436\u0434\u0435\u043d\u043d\u044b\u0445 \u043e\u0442 510(k)<\/a><\/strong> <sup><a href=\"#footnote-10\" id=\"ref-10\">10<\/a><\/sup>.<\/p>\n<hr \/>\n<h2>\u0417\u0430\u043a\u043b\u044e\u0447\u0435\u043d\u0438\u0435<\/h2>\n<p>\u041b\u044e\u0431\u0430\u044f \u043c\u0430\u0448\u0438\u043d\u0430 \u0434\u043b\u044f \u0443\u0434\u0430\u0440\u043d\u043e-\u0432\u043e\u043b\u043d\u043e\u0432\u043e\u0439 \u0442\u0435\u0440\u0430\u043f\u0438\u0438, \u0438\u043c\u043f\u043e\u0440\u0442\u0438\u0440\u0443\u0435\u043c\u0430\u044f \u0432 \u0421\u0428\u0410 \u0434\u043b\u044f \u043a\u043b\u0438\u043d\u0438\u0447\u0435\u0441\u043a\u043e\u0433\u043e \u0438\u0441\u043f\u043e\u043b\u044c\u0437\u043e\u0432\u0430\u043d\u0438\u044f, \u0434\u043e\u043b\u0436\u043d\u0430 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u043e\u0432\u0430\u0442\u044c \u043f\u0440\u0430\u0432\u0438\u043b\u0430\u043c FDA \u2014 \u043e\u0431\u044b\u0447\u043d\u043e \u043f\u043e\u0441\u0440\u0435\u0434\u0441\u0442\u0432\u043e\u043c \u043f\u043e\u043b\u0443\u0447\u0435\u043d\u0438\u044f \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u044f \u043f\u043e \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u0435 510(k) \u0438\u043b\u0438 PMA. \u0412\u0441\u0435\u0433\u0434\u0430 \u043f\u0440\u043e\u0432\u0435\u0440\u044f\u0439\u0442\u0435 \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u0435 \u0432 \u0431\u0430\u0437\u0435 \u0434\u0430\u043d\u043d\u044b\u0445 FDA, \u0437\u0430\u043f\u0440\u0430\u0448\u0438\u0432\u0430\u0439\u0442\u0435 \u043e\u0444\u0438\u0446\u0438\u0430\u043b\u044c\u043d\u044b\u0435 \u0434\u043e\u043a\u0443\u043c\u0435\u043d\u0442\u044b \u0443 \u0432\u0430\u0448\u0435\u0433\u043e \u043f\u043e\u0441\u0442\u0430\u0432\u0449\u0438\u043a\u0430 \u0438 \u0443\u0431\u0435\u0434\u0438\u0442\u0435\u0441\u044c, \u0447\u0442\u043e \u043c\u0430\u0440\u043a\u0438\u0440\u043e\u0432\u043a\u0430 \u0438 \u043c\u0430\u0440\u043a\u0435\u0442\u0438\u043d\u0433 \u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0443\u044e\u0442 \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u043d\u044b\u043c \u043f\u043e\u043a\u0430\u0437\u0430\u043d\u0438\u044f\u043c.<br \/>\n<strong>\u0421\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0438\u0435 \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f\u043c \u043d\u0435 \u044f\u0432\u043b\u044f\u0435\u0442\u0441\u044f \u043e\u043f\u0446\u0438\u0435\u0439 \u2014 \u044d\u0442\u043e \u043e\u0441\u043d\u043e\u0432\u0430 \u0437\u0430\u043a\u043e\u043d\u043d\u043e\u0433\u043e \u0438\u043c\u043f\u043e\u0440\u0442\u0430 \u0438 \u0431\u0435\u0437\u043e\u043f\u0430\u0441\u043d\u043e\u0439 \u044d\u043a\u0441\u043f\u043b\u0443\u0430\u0442\u0430\u0446\u0438\u0438 \u043d\u0430 \u0440\u044b\u043d\u043a\u0435 \u0421\u0428\u0410.<\/strong><\/p>\n<hr \/>\n<h2>\u0421\u043d\u043e\u0441\u043a\u0438<\/h2>\n<p><span id=\"footnote-1\">1. \u041e\u0431\u0437\u043e\u0440 \u043a\u043b\u0430\u0441\u0441\u0438\u0444\u0438\u043a\u0430\u0446\u0438\u0438 \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u0438\u0445 \u0438\u0437\u0434\u0435\u043b\u0438\u0439 FDA. <a href=\"#ref-1\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-2\">2. \u0420\u0443\u043a\u043e\u0432\u043e\u0434\u0441\u0442\u0432\u043e FDA \u043f\u043e \u0438\u043c\u043f\u043e\u0440\u0442\u0443 \u043f\u0430\u0440\u0442\u0438\u0439 \u043c\u0435\u0434\u0438\u0446\u0438\u043d\u0441\u043a\u0438\u0445 \u0438\u0437\u0434\u0435\u043b\u0438\u0439. <a href=\"#ref-2\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-3\">3. \u041f\u0440\u0435\u0434\u0443\u043f\u0440\u0435\u0436\u0434\u0435\u043d\u0438\u044f FDA \u043e\u0431 \u0438\u043c\u043f\u043e\u0440\u0442\u0435 \u043d\u0435\u0441\u043e\u043e\u0442\u0432\u0435\u0442\u0441\u0442\u0432\u0443\u044e\u0449\u0438\u0445 \u0442\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f\u043c \u043f\u0440\u043e\u0434\u0443\u043a\u0442\u043e\u0432. <a href=\"#ref-3\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-4\">4. \u0411\u0430\u0437\u0430 \u0434\u0430\u043d\u043d\u044b\u0445 \u0434\u043b\u044f \u043f\u043e\u0438\u0441\u043a\u0430 \u0440\u0430\u0437\u0440\u0435\u0448\u0435\u043d\u0438\u0439 FDA \u043f\u043e \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u0435 510(k). <a href=\"#ref-4\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-5\">5. \u0411\u0430\u0437\u0430 \u0434\u0430\u043d\u043d\u044b\u0445 \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u0438 \u0438 \u043f\u0435\u0440\u0435\u0447\u043d\u044f \u0438\u0437\u0434\u0435\u043b\u0438\u0439 FDA. <a href=\"#ref-5\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-6\">6. \u041f\u0443\u0442\u044c \u043a\u043b\u0430\u0441\u0441\u0438\u0444\u0438\u043a\u0430\u0446\u0438\u0438 De Novo \u0434\u043b\u044f \u043d\u043e\u0432\u044b\u0445 \u0438\u0437\u0434\u0435\u043b\u0438\u0439. <a href=\"#ref-6\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-7\">7. \u0420\u0435\u0433\u043b\u0430\u043c\u0435\u043d\u0442 \u0441\u0438\u0441\u0442\u0435\u043c\u044b \u043a\u0430\u0447\u0435\u0441\u0442\u0432\u0430 (21 CFR \u0427\u0430\u0441\u0442\u044c 820). <a href=\"#ref-7\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-8\">8. \u041f\u0440\u0430\u0432\u0438\u043b\u0430 FDA \u043f\u043e \u043c\u0430\u0440\u043a\u0438\u0440\u043e\u0432\u043a\u0435 \u0438 \u043f\u043e\u043a\u0430\u0437\u0430\u043d\u0438\u044f\u043c \u0434\u043b\u044f \u0438\u0437\u0434\u0435\u043b\u0438\u0439. <a href=\"#ref-8\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-9\">9. \u0422\u0440\u0435\u0431\u043e\u0432\u0430\u043d\u0438\u044f \u043a \u0440\u0435\u0433\u0438\u0441\u0442\u0440\u0430\u0446\u0438\u0438 \u0438 \u043f\u0440\u0435\u0434\u0441\u0442\u0430\u0432\u0438\u0442\u0435\u043b\u044e \u0432 \u0421\u0428\u0410. <a href=\"#ref-9\">\u21a9\ufe0e<\/a><\/span><br \/>\n<span id=\"footnote-10\">10. \u0421\u043f\u0438\u0441\u043e\u043a \u0438\u0437\u0434\u0435\u043b\u0438\u0439, \u043e\u0441\u0432\u043e\u0431\u043e\u0436\u0434\u0435\u043d\u043d\u044b\u0445 \u043e\u0442 \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440\u044b 510(k) FDA. <a href=\"#ref-10\">\u21a9\ufe0e<\/a><\/span>  <\/p>","protected":false},"excerpt":{"rendered":"<p>As a manufacturer that exports medical-grade shockwave therapy machines, I often help U.S. buyers confirm whether FDA clearance is mandatory. Many importers assume that a CE mark or ISO certification is enough\u2014but in the U.S., that\u2019s not the case. Yes, imported shockwave therapy machines must meet FDA requirements before they can be marketed, distributed, or [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":8174,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[60],"tags":[],"class_list":["post-8170","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-shockwave-therapy-machine"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.0 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Should Imported Shockwave Therapy Machines Meet FDA Requirements or Certification? - KMSLaser<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kmslaser.com\/ru\/\u0434\u043e\u043b\u0436\u043d\u044b-\u043b\u0438-\u0438\u043c\u043f\u043e\u0440\u0442\u0438\u0440\u0443\u0435\u043c\u044b\u0435-\u0430\u043f\u043f\u0430\u0440\u0430\u0442\u044b-\u0443\u0434\u0430\/\" \/>\n<meta property=\"og:locale\" content=\"ru_RU\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Should Imported Shockwave Therapy Machines Meet FDA Requirements or Certification?\" \/>\n<meta property=\"og:description\" content=\"As a manufacturer that exports medical-grade shockwave therapy machines, I often help U.S. buyers confirm whether FDA clearance is mandatory. Many importers assume that a CE mark or ISO certification is enough\u2014but in the U.S., that\u2019s not the case. 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