[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PMH":3},{"classification":4,"mappedDevices":29,"similarCandidates":30,"relatedClassifications":113,"syncDates":114,"translation":121,"marketSummary":128,"recalls":141,"k510s":143,"pmas":145},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":24,"updated_at":25,"recall_count":26,"latest_recall_date":27,"k510_count":26,"pma_count":26,"event_count":28},277,"PMH","Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)","f","","Unknown","GU","6","For treatment of fecal incontinence in patients who have failed conservative therapies",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":21,"product_code":6,"review_panel":11,"gmp_exempt_flag":22,"third_party_flag":22,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":22,"medical_specialty_description":10,"summary_malfunction_reporting":23},{"fei_number":18,"registration_number":20},[19],"3008766073",[19],"Y","N","Eligible","2026-08-18T05:52:47.660896+00:00","2026-08-24T02:00:48.758894+00:00",0,null,48,[],[31,40,49,58,66,74,82,90,97,106],{"medical_device_id":32,"generic_name":33,"class_classification":34,"jmdn_code":35,"name_similarity":36,"definition_similarity":37,"vector_similarity":38,"score":39},657,"機械式・水圧式植込み失禁器具","Ⅲ","31994000",0.344828,0.13871,0.755188,0.0325225,{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":46,"vector_similarity":47,"score":48},3179,"中耳加圧装置","Ⅱ","47542002",0.252747,0.0840336,0.669113,0.0269439,{"medical_device_id":50,"generic_name":51,"class_classification":52,"jmdn_code":53,"name_similarity":54,"definition_similarity":55,"vector_similarity":56,"score":57},4250,"失禁手術用クランプ","Ⅰ","35119000",0.220779,0.108911,0.671817,0.0245693,{"medical_device_id":59,"generic_name":60,"class_classification":43,"jmdn_code":61,"name_similarity":62,"definition_similarity":63,"vector_similarity":64,"score":65},2288,"手動式可搬型吸引器","36616010",0.21978,0.144628,0.667724,0.0242504,{"medical_device_id":67,"generic_name":68,"class_classification":34,"jmdn_code":69,"name_similarity":70,"definition_similarity":71,"vector_similarity":72,"score":73},838,"失禁用神経筋電気刺激装置","36784000",0.175258,0.17094,0.763361,0.0163934,{"medical_device_id":75,"generic_name":76,"class_classification":52,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":81},3739,"手動式圧注入調節装置","13100001",0.302326,0.144509,0.58818,0.016129,{"medical_device_id":83,"generic_name":84,"class_classification":34,"jmdn_code":85,"name_similarity":86,"definition_similarity":87,"vector_similarity":88,"score":89},664,"人工肛門括約筋補綴材","34092000",0.0222222,0.235772,0.74715,0.015873,{"medical_device_id":91,"generic_name":92,"class_classification":52,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":89},4329,"手動式手術用ドリル","36235001",0.282353,0.126263,0.618613,{"medical_device_id":98,"generic_name":99,"class_classification":100,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":105},302,"植込み型失禁用神経筋電気刺激装置","Ⅳ","36175000",0.157407,0.164502,0.742731,0.015625,{"medical_device_id":107,"generic_name":108,"class_classification":43,"jmdn_code":109,"name_similarity":110,"definition_similarity":111,"vector_similarity":112,"score":105},1358,"手動式造影剤注入装置","40721000",0.277778,0.101167,0.543572,[],{"510k":115,"classification":116,"enforcement":117,"event":118,"pma":119,"warning_letter":120},"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":122,"definition_ja":123,"commentary_ja":124,"model_name":125,"source_hash":126,"reviewed_by":27,"reviewed_at":27,"created_at":127,"updated_at":127},"便失禁用機械的圧迫装置（非手動操作式）","保存的治療に失敗した患者における便失禁の治療のためのものである。","この機器は米国においてHDE（人道機器免除）の対象として扱われています。HDEは、対象患者数が少ない疾患・状態に用いる機器について、有効性に関する厳密な証明を求めず、人道機器申請（HDE）という特別な審査区分を通じて市販を認める制度であり、通常のクラスIII機器に適用される市販前承認（PMA）とは異なる枠組みです。この区分は、対象患者数の少なさゆえに通常の臨床試験実施が困難な機器に対して、安全性を確認した上で人道的な観点から使用を可能にするものです。","claude-sonnet-5","83804247ec7c15f3b4b92cc5da9917edbbe1c6cb1575ea6a8a056de7f043b525","2026-08-24T02:33:49.041043+00:00",{"product_code":6,"summary_ja":129,"stats":130,"stats_hash":139,"model_name":125,"created_at":140,"updated_at":140},"本製品は人道機器申請（HDE）の区分であり、510(k)および PMA による市販前届出・承認の実績は確認されていません。不具合報告は累計約 50 件で、その全件が傷害として報告されており、死亡や不具合（Malfunction）に分類された報告は確認されていません。最新の報告は 2021 年 7 月時点となっています。回収については、クラス I を含め累計での報告は確認されていません。",{"pma":131,"k510":132,"as_of":133,"events":134,"recalls":136,"top_problems":138},{"latest":27,"originals":26,"supplements":26},{"total":26,"last5y":26,"latest":27,"applicants":26},"2026-08",{"death":26,"other":26,"total":28,"injury":28,"last5y":26,"malfunction":26,"latest_month":135},"2021-07",{"total":26,"last5y":26,"latest":27,"class_i":26,"class_ii":26,"class_iii":26,"top_root_causes":137},[],[],"d5241fd5771f5e80a3a26e704151a4459d5460e5dd53943ec8540ba120b2ffb8","2026-08-24T05:13:39.867404+00:00",{"items":142,"total":26},[],{"items":144,"total":26},[],{"items":146,"total":26},[]]