[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-HPG":3},{"classification":4,"mappedDevices":47,"similarCandidates":48,"relatedClassifications":120,"syncDates":125,"translation":132,"marketSummary":138,"recalls":152,"k510s":154,"pmas":183},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":42,"updated_at":43,"recall_count":44,"latest_recall_date":45,"k510_count":46,"pma_count":44,"event_count":44},5565,"HPG","Aid, Vision, Electronic, Battery-Powered","1","886.5900","OP","Ophthalmic","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":40,"product_code":6,"review_panel":10,"gmp_exempt_flag":40,"third_party_flag":40,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":40,"medical_specialty_description":11,"summary_malfunction_reporting":41},{"k_number":17,"fei_number":25,"registration_number":37},[18,19,20,21,22,23,24],"K823385","K910124","K903558","K761215","K910601","K902187","K862338",[26,27,28,29,30,31,32,33,34,35,36],"3009840810","3002807554","3045764822","3010577752","3003951061","3034880867","3014656175","3002968900","3014656174","3002540311","3042371163",[38,26,28,29,30,31,39,32,33,34,36],"9612197","8022025","N","Eligible","2026-08-18T05:52:52.949882+00:00","2026-08-24T02:00:48.095002+00:00",0,null,7,[],[49,57,65,71,78,86,93,100,107,114],{"medical_device_id":50,"generic_name":51,"class_classification":52,"jmdn_code":53,"name_similarity":54,"definition_similarity":44,"vector_similarity":55,"score":56},943,"電池電源式焼灼器","Ⅲ","35029000",0.403509,0.677736,0.0327869,{"medical_device_id":58,"generic_name":59,"class_classification":60,"jmdn_code":61,"name_similarity":62,"definition_similarity":44,"vector_similarity":63,"score":64},2898,"電池電源式関節手術用器械","Ⅱ","70964022",0.25,0.660723,0.0308349,{"medical_device_id":66,"generic_name":67,"class_classification":60,"jmdn_code":68,"name_similarity":62,"definition_similarity":44,"vector_similarity":69,"score":70},1775,"送気送水機能付バッテリー式内視鏡用光源装置","35906002",0.649461,0.0298507,{"medical_device_id":72,"generic_name":73,"class_classification":60,"jmdn_code":74,"name_similarity":75,"definition_similarity":44,"vector_similarity":76,"score":77},2883,"電池電源式手術用ドリル","37867010",0.253968,0.636603,0.0287179,{"medical_device_id":79,"generic_name":80,"class_classification":81,"jmdn_code":82,"name_similarity":83,"definition_similarity":44,"vector_similarity":84,"score":85},3434,"バッテリー式内視鏡用光源装置","Ⅰ","35906001",0.283333,0.62691,0.0275009,{"medical_device_id":87,"generic_name":88,"class_classification":60,"jmdn_code":89,"name_similarity":90,"definition_similarity":44,"vector_similarity":91,"score":92},2896,"電池電源式脊椎手術用器械","70963022",0.225352,0.639544,0.0272222,{"medical_device_id":94,"generic_name":95,"class_classification":60,"jmdn_code":96,"name_similarity":97,"definition_similarity":44,"vector_similarity":98,"score":99},2558,"電池式トレパン","32820000",0.296296,0.573671,0.016129,{"medical_device_id":101,"generic_name":102,"class_classification":81,"jmdn_code":103,"name_similarity":104,"definition_similarity":44,"vector_similarity":105,"score":106},3876,"汎用電動式手術台","36867020",0.151515,0.654864,0.015873,{"medical_device_id":108,"generic_name":109,"class_classification":60,"jmdn_code":110,"name_similarity":111,"definition_similarity":44,"vector_similarity":112,"score":113},2836,"電動式ケラトーム","12222002",0.170213,0.653455,0.015625,{"medical_device_id":115,"generic_name":116,"class_classification":81,"jmdn_code":117,"name_similarity":118,"definition_similarity":44,"vector_similarity":119,"score":113},3875,"電池式移動型手術室用テーブルトップカラム","44145000",0.264706,0.616523,[121],{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"HPF","Aid, Vision, Electronic, Ac-Powered",1,{"510k":126,"classification":127,"enforcement":128,"event":129,"pma":130,"warning_letter":131},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":133,"definition_ja":45,"commentary_ja":134,"model_name":135,"source_hash":136,"reviewed_by":45,"reviewed_at":45,"created_at":137,"updated_at":137},"電池式電子視覚補助具","本品は電池で駆動する電子式の視覚補助具です。米国では医療機器のリスクに応じてクラスI・II・IIIに分類されますが、本品はクラスIに区分されており、市販前届出（510(k)）が免除される機器です。","claude-sonnet-5","4aafe776fee062e82a11c03cb243e268cef07b060d7112323e893e538cc24f37","2026-08-24T01:56:53.662172+00:00",{"product_code":6,"summary_ja":139,"stats":140,"stats_hash":150,"model_name":135,"created_at":151,"updated_at":151},"510(k)の累計件数は7件、参入企業数は5社ですが、直近5年間の届出実績はなく、最新の判定は1991年5月となっています。PMA（市販前承認）の申請実績は確認されていません。不具合報告（MDR）および回収（リコール）については、いずれも累計件数が0件であり、報告や回収の事例は確認されていません。",{"pma":141,"k510":142,"as_of":145,"events":146,"recalls":147,"top_problems":149},{"latest":45,"originals":44,"supplements":44},{"total":46,"last5y":44,"latest":143,"applicants":144},"1991-05-14",5,"2026-08",{"death":44,"other":44,"total":44,"injury":44,"last5y":44,"malfunction":44,"latest_month":45},{"total":44,"last5y":44,"latest":45,"class_i":44,"class_ii":44,"class_iii":44,"top_root_causes":148},[],[],"3897df77a613a5a8cfe889250755663377f29cb7701bfe4cf0d94a0d290c8091","2026-08-24T04:34:15.487438+00:00",{"items":153,"total":44},[],{"items":155,"total":46},[156,161,165,168,171,175,179],{"k_number":22,"device_name":157,"applicant":158,"decision_date":143,"clearance_type":159,"decision_code":160,"statement_or_summary":45},"PATHFINDER","Nurion Industries","Traditional","SESE",{"k_number":19,"device_name":162,"applicant":163,"decision_date":164,"clearance_type":159,"decision_code":160,"statement_or_summary":45},"LOW VISION ENHANCEMENT SYSTEM (LVES)","Triangle Investments","1991-04-10",{"k_number":20,"device_name":166,"applicant":158,"decision_date":167,"clearance_type":159,"decision_code":160,"statement_or_summary":45},"LASER CANE","1990-09-27",{"k_number":23,"device_name":169,"applicant":158,"decision_date":170,"clearance_type":159,"decision_code":160,"statement_or_summary":45},"POLARON","1990-08-08",{"k_number":24,"device_name":172,"applicant":173,"decision_date":174,"clearance_type":159,"decision_code":160,"statement_or_summary":45},"SENSORY 6","Brytech, Inc.","1986-09-03",{"k_number":18,"device_name":176,"applicant":177,"decision_date":178,"clearance_type":159,"decision_code":160,"statement_or_summary":45},"ALES","Oms","1983-03-09",{"k_number":21,"device_name":180,"applicant":181,"decision_date":182,"clearance_type":159,"decision_code":160,"statement_or_summary":45},"F4912 NIGHT VISION AID","Itt Corp.","1976-12-16",{"items":184,"total":44},[]]