{"id":7689,"date":"2023-03-29T13:51:14","date_gmt":"2023-03-29T05:51:14","guid":{"rendered":"https:\/\/be.tworg.app\/%e5%bf%ab%e9%80%9f%e4%ba%86%e8%a7%a3%e3%80%8c%e9%86%ab%e9%9b%bb%e7%94%a2%e5%93%81%e3%80%8d%e7%9a%84%e9%a9%97%e8%ad%89%e9%9c%80%e6%b1%82%ef%bc%81%e4%b8%8a\/"},"modified":"2025-11-03T14:26:41","modified_gmt":"2025-11-03T06:26:41","slug":"%e5%8c%bb%e7%99%82%e9%9b%bb%e6%b0%97%e6%a9%9f%e5%99%a8%e3%81%ae%e6%a4%9c%e8%a8%bc%e8%a6%81%e4%bb%b6%e3%82%92%e3%81%99%e3%81%b0%e3%82%84%e3%81%8f%e7%90%86%e8%a7%a3%e3%81%99%e3%82%8b%ef%bc%81%ef%bc%88-2","status":"publish","type":"post","link":"https:\/\/behealthventures.com\/ja\/%e5%8c%bb%e7%99%82%e9%9b%bb%e6%b0%97%e6%a9%9f%e5%99%a8%e3%81%ae%e6%a4%9c%e8%a8%bc%e8%a6%81%e4%bb%b6%e3%82%92%e3%81%99%e3%81%b0%e3%82%84%e3%81%8f%e7%90%86%e8%a7%a3%e3%81%99%e3%82%8b%ef%bc%81%ef%bc%88-2\/","title":{"rendered":"\u533b\u7642\u96fb\u6c17\u6a5f\u5668\u306e\u691c\u8a3c\u8981\u4ef6\u3092\u3059\u3070\u3084\u304f\u7406\u89e3\u3059\u308b\uff01\uff08\u524d\u7de8\uff09"},"content":{"rendered":"<div 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src=\"http:\/\/be.tworg.app\/wp-content\/uploads\/2025\/08\/2e16c0_81b7101d62db41118d57a969a2fca3b4mv2.jpg\" alt=\"ree\" data-pin-url=\"https:\/\/behealthventures.com\/post\/\u5feb\u901f\u4e86\u89e3\u300c\u91ab\u96fb\u7522\u54c1\u300d\u7684\u9a57\u8b49\u9700\u6c42\uff01-\u4e0a\" data-pin-media=\"https:\/\/static.wixstatic.com\/media\/2e16c0_81b7101d62db41118d57a969a2fca3b4~mv2.jpg\/v1\/fill\/w_4932,h_3288,al_c,q_90\/2e16c0_81b7101d62db41118d57a969a2fca3b4~mv2.jpg\" data-load-done=\"\" \/><\/div>\n<\/div>\n<\/figure>\n<\/div>\n<\/div>\n<\/div>\n<div data-breakout=\"normal\">\n<h3 data-start=\"4878\" data-end=\"4901\"><strong data-start=\"4882\" data-end=\"4901\">\u533b\u7642\u6a5f\u5668\u306e\u672c\u8cea\uff1a\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027<\/strong><\/h3>\n<p data-start=\"4903\" data-end=\"5081\">\u533b\u7642\u6a5f\u5668\u306e\u6838\u5fc3\u306f\u3001<strong data-start=\"4912\" data-end=\"4929\">\u5b89\u5168\u3067\u52b9\u679c\u7684\u306b\u6a5f\u80fd\u3059\u308b\u3053\u3068<\/strong>\u306b\u3042\u308a\u307e\u3059\u3002<br data-start=\"4935\" data-end=\"4938\" \/>\u305d\u306e\u305f\u3081\u3001\u88fd\u54c1\u304c\u4e3b\u5f35\u3059\u308b\u6027\u80fd\u3092\u9054\u6210\u3059\u308b\u306b\u306f\u3001\u30ea\u30b9\u30af\u3092\u53d7\u3051\u5165\u308c\u53ef\u80fd\u306a\u6c34\u6e96\u307e\u3067\u4f4e\u6e1b\u3057\u3001<strong data-start=\"4979\" data-end=\"4989\">\u54c1\u8cea\u7ba1\u7406\u6587\u66f8<\/strong>\u3084<strong data-start=\"4990\" data-end=\"4998\">\u6280\u8853\u6587\u66f8<\/strong>\uff08\u8a66\u9a13\u5831\u544a\u66f8\u3001\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u306a\u3069\uff09\u3092\u901a\u3058\u3066\u305d\u306e\u59a5\u5f53\u6027\u3092\u7acb\u8a3c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<br data-start=\"5037\" data-end=\"5040\" \/>\u3053\u308c\u306b\u3088\u308a\u3001\u88fd\u54c1\u304c<strong data-start=\"5049\" data-end=\"5069\">\u5b89\u5168\u304b\u3064\u4fe1\u983c\u6027\u3092\u3082\u3063\u3066\u4f7f\u7528\u3067\u304d\u308b<\/strong>\u3053\u3068\u304c\u4fdd\u8a3c\u3055\u308c\u307e\u3059\u3002<\/p>\n<h2 data-start=\"838\" data-end=\"899\"><strong data-start=\"842\" data-end=\"899\">FDA\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306e\u5b9a\u7fa9<\/strong><\/h2>\n<p data-start=\"5112\" data-end=\"5190\">\u307e\u305a\u3001\u533b\u7642\u6a5f\u5668\u3068\u306f\u4f55\u304b\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<br data-start=\"5136\" data-end=\"5139\" \/>\u56fd\u3054\u3068\u306b\u5b9a\u7fa9\u306f\u3084\u3084\u7570\u306a\u308a\u307e\u3059\u304c\u3001**\u30a2\u30e1\u30ea\u30ab\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09**\u306f\u6b21\u306e\u3088\u3046\u306b\u5b9a\u7fa9\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<blockquote data-start=\"5192\" data-end=\"5282\">\n<p data-start=\"5194\" data-end=\"5282\">\u300c\u4eba\u307e\u305f\u306f\u52d5\u7269\u306e\u75be\u75c5\u306e\u8a3a\u65ad\u30fb\u6cbb\u7642\u30fb\u4e88\u9632\u30fb\u7de9\u548c\u3092\u76ee\u7684\u3068\u3059\u308b\u6a5f\u5668\u30fb\u88c5\u7f6e\u30fb\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u30fb\u4f53\u5916\u8a3a\u65ad\u85ac\u306a\u3069\u3001\u8eab\u4f53\u306e\u69cb\u9020\u307e\u305f\u306f\u6a5f\u80fd\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u304c\u3001\u5316\u5b66\u7684\u4f5c\u7528\u3084\u4ee3\u8b1d\u306b\u4f9d\u5b58\u3057\u306a\u3044\u3082\u306e\u3002\u300d<\/p>\n<\/blockquote>\n<p data-start=\"5284\" data-end=\"5462\">FDA\u306f\u533b\u7642\u6a5f\u5668\u3092\u30ea\u30b9\u30af\u306b\u57fa\u3065\u304d<strong data-start=\"5300\" data-end=\"5385\">Class I\uff08\u4f4e\u30ea\u30b9\u30af\uff09\uff5eClass III\uff08\u9ad8\u30ea\u30b9\u30af\uff09\u306e3\u3064\u306b\u5206\u985e\u3057\u3066\u304a\u308a\u3001\u898f\u5236\u306e\u53b3\u3057\u3055\u306f\u30ea\u30b9\u30af\u306e\u9ad8\u3055\u306b\u6bd4\u4f8b\u3057\u307e\u3059\u3002<br data-start=\"5364\" data-end=\"5367\" \/>\u591a\u304f\u306e\u975e\u4fb5\u8972\u7684\u306a\u533b\u7642\u96fb\u6c17\u6a5f\u5668<\/strong>\u306f<strong data-start=\"5386\" data-end=\"5403\">\u4e2d\u30ea\u30b9\u30af\u306eClass II<\/strong>\u306b\u8a72\u5f53\u3057\u3001<strong data-start=\"5408\" data-end=\"5442\">Premarket Notification\uff08510(k))<\/strong> \u3068\u547c\u3070\u308c\u308b\u7533\u8acb\u3092\u7d4c\u3066\u4e0a\u5e02\u3055\u308c\u307e\u3059\u3002<\/p>\n<\/div>\n<div data-breakout=\"normal\">\n<h2 id=\"viewer-djtp2\" class=\"Xni8y _3z5wP z3yvg logrL\" dir=\"auto\"><span class=\"kdaK-\"><strong>\u533b\u7642\u6a5f\u5668\u306e\u4e0a\u5e02\u8a31\u53ef\u7533\u8acb<\/strong><\/span><\/h2>\n<\/div>\n<div data-breakout=\"normal\">\n<p data-start=\"5490\" data-end=\"5571\">\u533b\u7642\u6a5f\u5668\u306e\u627f\u8a8d\u7533\u8acb\u3067\u306f\u3001**Intended Use\uff08\u76ee\u7684\u7528\u9014\uff09<strong data-start=\"5522\" data-end=\"5527\">\u3068<\/strong>Indications for Use\uff08\u9069\u5fdc\u75c7\uff09**\u3092\u660e\u78ba\u306b\u5b9a\u7fa9\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<ul data-start=\"5573\" data-end=\"5677\">\n<li data-start=\"5573\" data-end=\"5613\">\n<p data-start=\"5575\" data-end=\"5613\"><strong data-start=\"5575\" data-end=\"5597\">Intended Use\uff08\u76ee\u7684\u7528\u9014\uff09<\/strong>\uff1a\u88fd\u54c1\u306e\u5168\u4f53\u7684\u306a\u7528\u9014\u3084\u6a5f\u80fd\u3002<\/p>\n<\/li>\n<li data-start=\"5614\" data-end=\"5677\">\n<p data-start=\"5616\" data-end=\"5677\"><strong data-start=\"5616\" data-end=\"5644\">Indications for Use\uff08\u9069\u5fdc\u75c7\uff09<\/strong>\uff1a\u8a3a\u65ad\u30fb\u6cbb\u7642\u30fb\u4e88\u9632\u306a\u3069\u306b\u304a\u3051\u308b\u5177\u4f53\u7684\u306a\u5bfe\u8c61\u75be\u60a3\u3084\u60a3\u8005\u5c64\u306e\u8aac\u660e\u3002<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"5679\" data-end=\"5730\">\u4e21\u8005\u306f\u5bc6\u63a5\u306b\u95a2\u9023\u3057\u3066\u3044\u307e\u3059\u304c\u3001**\u9069\u5fdc\u75c7\u306f\u76ee\u7684\u7528\u9014\u306e\u4e00\u90e8\uff08\u30b5\u30d6\u30bb\u30c3\u30c8\uff09**\u3068\u3057\u3066\u4f4d\u7f6e\u3065\u3051\u3089\u308c\u307e\u3059\u3002<\/p>\n<\/div>\n<div data-breakout=\"normal\">\n<h3 data-start=\"5737\" data-end=\"5754\"><strong data-start=\"5741\" data-end=\"5754\">\u4f8b\uff1a\u8d85\u97f3\u6ce2\u8a3a\u65ad\u88c5\u7f6e<\/strong><\/h3>\n<p data-start=\"5756\" data-end=\"5960\">FDA\u306e\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306b\u767b\u9332\u3055\u308c\u3066\u3044\u308b<strong data-start=\"5774\" data-end=\"5787\">\u6c4e\u7528\u8d85\u97f3\u6ce2\u8a3a\u65ad\u88c5\u7f6e<\/strong>\u306f\u3001<strong data-start=\"5789\" data-end=\"5801\">Class II<\/strong> \u306b\u5206\u985e\u3055\u308c\u3001<strong data-start=\"5808\" data-end=\"5818\">510(k)<\/strong> \u30d7\u30ed\u30bb\u30b9\u3092\u7d4c\u3066\u627f\u8a8d\u3055\u308c\u3066\u3044\u307e\u3059\u3002<br data-start=\"5835\" data-end=\"5838\" \/>\u305d\u306e**Intended Use\uff08\u76ee\u7684\u7528\u9014\uff09**\u306f\u300c\u4eba\u4f53\u306b\u304a\u3051\u308b\u8d85\u97f3\u6ce2\u753b\u50cf\u8a3a\u65ad\u304a\u3088\u3073\u6d41\u4f53\u6d41\u52d5\u89e3\u6790\u300d\u3067\u3042\u308a\u3001<br data-start=\"5891\" data-end=\"5894\" \/>**Indications for Use\uff08\u9069\u5fdc\u75c7\uff09**\u3067\u306f\u300c\u5fc3\u81d3\u753b\u50cf\u8a3a\u65ad\u306b\u7279\u5316\u3057\u305f\u6c4e\u7528\u8d85\u97f3\u6ce2\u8a3a\u65ad\u30b7\u30b9\u30c6\u30e0\u300d\u3068\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p data-start=\"5962\" data-end=\"6079\">\u4f7f\u7528\u4f8b\u3068\u3057\u3066\uff1a<br data-start=\"5969\" data-end=\"5972\" \/>\u80ce\u5150\u30fb\u7523\u79d1\u3001\u8179\u90e8\uff08\u814e\u81d3\u30fb\u5a66\u4eba\u79d1\uff09\u3001\u5c0f\u5150\u3001\u5c0f\u5668\u5b98\uff08\u4e73\u817a\u30fb\u7cbe\u5de3\u30fb\u7532\u72b6\u817a\uff09\u3001\u65b0\u751f\u5150\u982d\u90e8\u3001\u6210\u4eba\u982d\u90e8\u3001\u5fc3\u81d3\uff08\u6210\u4eba\u30fb\u5c0f\u5150\uff09\u3001\u672b\u68a2\u8840\u7ba1\u3001\u7b4b\u9aa8\u683c\u3001\u6ccc\u5c3f\u5668\uff08\u524d\u7acb\u817a\u3092\u542b\u3080\uff09\u306a\u3069\u3001<br data-start=\"6051\" data-end=\"6054\" \/>\u3055\u3089\u306b\u7d4c\u98df\u9053\u30fb\u7d4c\u76f4\u8178\u30fb\u7d4c\u81a3\u306e\u5fdc\u7528\u3082\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n<h3 data-start=\"6086\" data-end=\"6098\"><strong data-start=\"6090\" data-end=\"6098\">\u6b21\u56de\u4e88\u544a<\/strong><\/h3>\n<p data-start=\"6100\" data-end=\"6201\">\u6b21\u56de\u306e\u5f8c\u7de8\u3067\u306f\u3001\u533b\u7642\u96fb\u6c17\u6a5f\u5668\u306b\u5fc5\u8981\u306a<strong data-start=\"6118\" data-end=\"6133\">\u4e3b\u8981\u8a66\u9a13\u304a\u3088\u3073\u691c\u8a3c\u8981\u4ef6<\/strong>\u3092\u89e3\u8aac\u3057\u307e\u3059\u3002<br data-start=\"6140\" data-end=\"6143\" \/>\u88fd\u54c1\u958b\u767a\u30c1\u30fc\u30e0\u306e<strong data-start=\"6151\" data-end=\"6169\">\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u7b56\u5b9a\u3084\u30ea\u30b9\u30af\u7ba1\u7406<\/strong>\u3001\u6295\u8cc7\u5bb6\u306e<strong data-start=\"6174\" data-end=\"6189\">\u30c7\u30e5\u30fc\u30c7\u30ea\u30b8\u30a7\u30f3\u30b9\u8a55\u4fa1<\/strong>\u306b\u3082\u5f79\u7acb\u3064\u5185\u5bb9\u3067\u3059\u3002<\/p>\n<p data-start=\"6203\" data-end=\"6238\">\u304a\u554f\u3044\u5408\u308f\u305b\uff1a<strong data-start=\"6210\" data-end=\"6238\"><a class=\"decorated-link cursor-pointer\" rel=\"noopener\" data-start=\"6212\" data-end=\"6236\">Joseph.Shen@be.tworg.app<\/a><\/strong><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u533b\u7642\u6a5f\u5668\u306f\u4eba\u4f53\u306b\u76f4\u63a5\u4f7f\u7528\u3055\u308c\u308b\u305f\u3081\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u304c\u6700\u3082\u91cd\u8981\u3067\u3059\u3002 \u305d\u306e\u305f\u3081\u3001\u5404\u56fd\u306e\u898f\u5236\u5f53\u5c40\u306f\u975e\u5e38\u306b\u53b3\u683c\u306a\u691c\u8a3c\u30fb\u8a8d\u8a3c\u30d7\u30ed\u30bb\u30b9\u3092\u6c42\u3081\u3066\u3044\u307e\u3059\u3002 \u672c\u7a3f\u3067\u306f\u3001\u975e\u57cb\u8fbc\u578b\u30fb\u96fb\u6e90\u3092\u6709\u3059\u308b\u533b\u7642\u6a5f\u5668\u3092\u5bfe\u8c61\u306b\u3001\u958b\u767a\u30c1\u30fc\u30e0\u3084\u6295\u8cc7\u5bb6\u304c\u7406\u89e3\u3057\u3066 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6899,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35],"tags":[],"class_list":["post-7689","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-article"],"acf":[],"_links":{"self":[{"href":"https:\/\/behealthventures.com\/ja\/wp-json\/wp\/v2\/posts\/7689","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/behealthventures.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/behealthventures.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/behealthventures.com\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/behealthventures.com\/ja\/wp-json\/wp\/v2\/comments?post=7689"}],"version-history":[{"count":3,"href":"https:\/\/behealthventures.com\/ja\/wp-json\/wp\/v2\/posts\/7689\/revisions"}],"predecessor-version":[{"id":7695,"href":"https:\/\/behealthventures.com\/ja\/wp-json\/wp\/v2\/posts\/7689\/revisions\/7695"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/behealthventures.com\/ja\/wp-json\/wp\/v2\/media\/6899"}],"wp:attachment":[{"href":"https:\/\/behealthventures.com\/ja\/wp-json\/wp\/v2\/media?parent=7689"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/behealthventures.com\/ja\/wp-json\/wp\/v2\/categories?post=7689"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/behealthventures.com\/ja\/wp-json\/wp\/v2\/tags?post=7689"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}