[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-HCB":3},{"classification":4,"mappedDevices":37,"similarCandidates":38,"relatedClassifications":108,"syncDates":109,"translation":116,"marketSummary":122,"recalls":137,"k510s":139,"pmas":167},{"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":31,"updated_at":32,"recall_count":33,"latest_recall_date":34,"k510_count":35,"pma_count":33,"event_count":36},879,"HCB","Device, Aversive Conditioning","2","882.5235","NE","Neurology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":28,"product_code":6,"review_panel":10,"gmp_exempt_flag":28,"third_party_flag":29,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":28,"medical_specialty_description":11,"summary_malfunction_reporting":30},{"k_number":17,"fei_number":24,"registration_number":26},[18,19,20,21,22,23],"K790738","K820622","K911820","K760166","K871158","K853178",[25],"1000120805",[27],"1222743","N","Y","Ineligible","2026-08-18T05:52:48.222586+00:00","2026-08-24T02:00:48.758894+00:00",0,null,6,2,[],[39,47,55,61,69,76,82,89,95,102],{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":33,"vector_similarity":45,"score":46},253,"強膜バックリング用器具","Ⅳ","15794000",0.204545,0.629158,0.0276233,{"medical_device_id":48,"generic_name":49,"class_classification":50,"jmdn_code":51,"name_similarity":52,"definition_similarity":33,"vector_similarity":53,"score":54},808,"能動型機器接続用酸素濃縮器","Ⅲ","12873003",0.304348,0.592643,0.0163934,{"medical_device_id":56,"generic_name":57,"class_classification":58,"jmdn_code":59,"name_similarity":33,"definition_similarity":33,"vector_similarity":60,"score":54},2539,"行動療法用電気刺激装置","Ⅱ","34875000",0.693927,{"medical_device_id":62,"generic_name":63,"class_classification":64,"jmdn_code":65,"name_similarity":66,"definition_similarity":33,"vector_similarity":67,"score":68},4155,"歯科用研削器材","Ⅰ","70908000",0.282051,0.521867,0.016129,{"medical_device_id":70,"generic_name":71,"class_classification":58,"jmdn_code":72,"name_similarity":73,"definition_similarity":33,"vector_similarity":74,"score":75},2778,"歯面処理材","70859000",0.27451,0.610943,0.015873,{"medical_device_id":77,"generic_name":78,"class_classification":58,"jmdn_code":79,"name_similarity":80,"definition_similarity":33,"vector_similarity":81,"score":75},2948,"電位・電気マッサージ組合せ家庭用医療機器","71003000",0.1125,0.626856,{"medical_device_id":83,"generic_name":84,"class_classification":58,"jmdn_code":85,"name_similarity":86,"definition_similarity":33,"vector_similarity":87,"score":88},2244,"尿失禁防止用具","70431000",0.0615385,0.626678,0.015625,{"medical_device_id":90,"generic_name":91,"class_classification":58,"jmdn_code":92,"name_similarity":93,"definition_similarity":33,"vector_similarity":94,"score":88},2314,"能動型機器接続歯科用シリンジ","35970012",0.269231,0.573031,{"medical_device_id":96,"generic_name":97,"class_classification":58,"jmdn_code":98,"name_similarity":99,"definition_similarity":33,"vector_similarity":100,"score":101},2022,"圧力モニタリング用ダンピングデバイス","70270000",0.196078,0.62559,0.0153846,{"medical_device_id":103,"generic_name":104,"class_classification":64,"jmdn_code":105,"name_similarity":106,"definition_similarity":33,"vector_similarity":107,"score":101},3588,"自動染色装置","70191000",0.25,0.526333,[],{"510k":110,"classification":111,"enforcement":112,"event":113,"pma":114,"warning_letter":115},"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":117,"definition_ja":34,"commentary_ja":118,"model_name":119,"source_hash":120,"reviewed_by":34,"reviewed_at":34,"created_at":121,"updated_at":121},"嫌悪条件付け装置","この機器は、不適切または有害な行動を抑制するために、電気刺激などの嫌悪刺激を与えて条件付けを行う装置です。米国ではクラスIIに分類されており、市販前届出（510(k)）による審査を経て市販が認められます。クラスIIは、一般的な管理規制に加えて特別な管理が必要とされる中程度のリスクを持つ医療機器区分です。","claude-sonnet-5","e0f52c835d8e7039cde1e8561df6ad8a092353f2ca0f39789b1d5bd7f761a95f","2026-08-24T01:55:21.85667+00:00",{"product_code":6,"summary_ja":123,"stats":124,"stats_hash":135,"model_name":119,"created_at":136,"updated_at":136},"本製品コードにおける510(k)の累計件数は6件で、参入企業数も6社となっていますが、直近5年間の届出実績や最新の判定は1994年12月からとなっています。不具合報告は累計約2件で、死亡・傷害の報告は確認されておらず、不具合（Malfunction）とその他がそれぞれ1件ずつとなっています。回収については累計件数0件で、クラスI・II・IIIいずれも確認されていません。",{"pma":125,"k510":126,"as_of":128,"events":129,"recalls":132,"top_problems":134},{"latest":34,"originals":33,"supplements":33},{"total":35,"last5y":33,"latest":127,"applicants":35},"1994-12-05","2026-08",{"death":33,"other":130,"total":36,"injury":33,"last5y":33,"malfunction":130,"latest_month":131},1,"2017-06",{"total":33,"last5y":33,"latest":34,"class_i":33,"class_ii":33,"class_iii":33,"top_root_causes":133},[],[],"ea0a3e311b6413a2dc0ac1dbbd6f8225d3fbf4cbb08b51f2d75b0c9dd87bbd0e","2026-08-24T04:30:57.116764+00:00",{"items":138,"total":33},[],{"items":140,"total":35},[141,147,151,155,159,163],{"k_number":20,"device_name":142,"applicant":143,"decision_date":127,"clearance_type":144,"decision_code":145,"statement_or_summary":146},"GED (GRADUATED ELECTRONIC DECELERATOR","Behavior Research Institute, Inc.","Traditional","SESE","Statement",{"k_number":22,"device_name":148,"applicant":149,"decision_date":150,"clearance_type":144,"decision_code":145,"statement_or_summary":34},"SIBIS REMOTE ACTUATOR","Human Technologies, Inc.","1987-05-29",{"k_number":23,"device_name":152,"applicant":153,"decision_date":154,"clearance_type":144,"decision_code":145,"statement_or_summary":34},"SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM","Oxford Medilog, Inc.","1986-02-28",{"k_number":19,"device_name":156,"applicant":157,"decision_date":158,"clearance_type":144,"decision_code":145,"statement_or_summary":34},"ELECTROSTIMULI AVERSION MACHINE","Michael R. Kiss","1982-04-09",{"k_number":18,"device_name":160,"applicant":161,"decision_date":162,"clearance_type":144,"decision_code":145,"statement_or_summary":34},"HABITSABATER","Jackson Ent.","1979-06-20",{"k_number":21,"device_name":164,"applicant":165,"decision_date":166,"clearance_type":144,"decision_code":145,"statement_or_summary":34},"STIMULATOR, SONIC CONTROL (AS-1)","Farrall Instruments, Inc.","1976-07-20",{"items":168,"total":33},[]]