[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LWB":3},{"classification":4,"mappedDevices":25,"similarCandidates":26,"relatedClassifications":100,"syncDates":101,"translation":108,"marketSummary":114,"recalls":129,"k510s":131,"pmas":133},{"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":9,"implant_flag":13,"life_sustain_support_flag":13,"gmp_exempt_flag":13,"raw":14,"created_at":20,"updated_at":21,"recall_count":22,"latest_recall_date":23,"k510_count":22,"pma_count":24,"event_count":22},5347,"LWB","Stimulator, Functional Neuromuscular, Scoliosis","3","","Unknown","PM","2",false,{"openfda":15,"definition":9,"device_name":7,"review_code":9,"device_class":8,"implant_flag":18,"product_code":6,"review_panel":11,"gmp_exempt_flag":18,"third_party_flag":18,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":18,"medical_specialty_description":10,"summary_malfunction_reporting":19},{"pma_number":16},[17],"P820008","N","Ineligible","2026-08-18T05:52:52.566809+00:00","2026-08-24T02:00:49.169481+00:00",0,null,6,[],[27,35,42,49,56,64,71,78,86,93],{"medical_device_id":28,"generic_name":29,"class_classification":30,"jmdn_code":31,"name_similarity":32,"definition_similarity":22,"vector_similarity":33,"score":34},2462,"脊柱側弯症用神経筋電気刺激装置","Ⅱ","36006000",0.62963,0.857953,0.0327869,{"medical_device_id":36,"generic_name":37,"class_classification":30,"jmdn_code":38,"name_similarity":39,"definition_similarity":22,"vector_similarity":40,"score":41},2461,"歩行神経筋電気刺激装置","35725000",0.423729,0.738196,0.031746,{"medical_device_id":43,"generic_name":44,"class_classification":30,"jmdn_code":45,"name_similarity":46,"definition_similarity":22,"vector_similarity":47,"score":48},2532,"射精神経筋電気刺激装置","17912000",0.451613,0.725285,0.0306218,{"medical_device_id":50,"generic_name":51,"class_classification":30,"jmdn_code":52,"name_similarity":53,"definition_similarity":22,"vector_similarity":54,"score":55},1471,"診断用神経筋電気刺激装置","35729000",0.390625,0.727104,0.0303309,{"medical_device_id":57,"generic_name":58,"class_classification":59,"jmdn_code":60,"name_similarity":61,"definition_similarity":22,"vector_similarity":62,"score":63},300,"排尿・排便用神経筋電気刺激装置","Ⅳ","35641000",0.36,0.73146,0.030303,{"medical_device_id":65,"generic_name":66,"class_classification":30,"jmdn_code":67,"name_similarity":68,"definition_similarity":22,"vector_similarity":69,"score":70},2463,"汎用機能式筋肉電気刺激装置","70598000",0.349206,0.761073,0.0302135,{"medical_device_id":72,"generic_name":73,"class_classification":59,"jmdn_code":74,"name_similarity":75,"definition_similarity":22,"vector_similarity":76,"score":77},296,"植込み型歩行用神経筋電気刺激装置","37856000",0.352113,0.732896,0.0300905,{"medical_device_id":79,"generic_name":80,"class_classification":81,"jmdn_code":82,"name_similarity":83,"definition_similarity":22,"vector_similarity":84,"score":85},838,"失禁用神経筋電気刺激装置","Ⅲ","36784000",0.373134,0.720282,0.0292735,{"medical_device_id":87,"generic_name":88,"class_classification":30,"jmdn_code":89,"name_similarity":90,"definition_similarity":22,"vector_similarity":91,"score":92},2607,"歯科用両側性筋電気刺激装置","70706000",0.328571,0.729435,0.0288143,{"medical_device_id":94,"generic_name":95,"class_classification":30,"jmdn_code":96,"name_similarity":97,"definition_similarity":22,"vector_similarity":98,"score":99},1615,"回転・振子・直線加速度刺激装置","70098000",0.264706,0.735231,0.028612,[],{"510k":102,"classification":103,"enforcement":104,"event":105,"pma":106,"warning_letter":107},"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":109,"definition_ja":23,"commentary_ja":110,"model_name":111,"source_hash":112,"reviewed_by":23,"reviewed_at":23,"created_at":113,"updated_at":113},"側弯症治療用機能的神経筋刺激装置","この機器は米国においてクラスIIIに分類されており、市販前承認（PMA）による審査対象となっています。クラスIIIはFDAの分類制度の中で最もリスクが高い区分とされ、有効性と安全性に関する科学的根拠を示す厳格な審査プロセスを経なければ市販が認められません。","claude-sonnet-5","152ee5fc2265665f392d9903418cd86502db081e182e553cd6a197aa62e16455","2026-08-24T02:13:33.96397+00:00",{"product_code":6,"summary_ja":115,"stats":116,"stats_hash":127,"model_name":111,"created_at":128,"updated_at":128},"本製品はPMA区分での審査対象であり、本承認1件と一部変更承認5件が確認されており、最新の判定は1987年4月となっています。不具合報告および回収については、いずれも累計件数が0件であり、報告・実施の実績は確認されていません。",{"pma":117,"k510":121,"as_of":122,"events":123,"recalls":124,"top_problems":126},{"latest":118,"originals":119,"supplements":120},"1987-04-02",1,5,{"total":22,"last5y":22,"latest":23,"applicants":22},"2026-08",{"death":22,"other":22,"total":22,"injury":22,"last5y":22,"malfunction":22,"latest_month":23},{"total":22,"last5y":22,"latest":23,"class_i":22,"class_ii":22,"class_iii":22,"top_root_causes":125},[],[],"5b0aee69351003d65b7ef0aecce044721d8e82ba92b88c8926295784f0ccb4d9","2026-08-24T04:52:46.442187+00:00",{"items":130,"total":22},[],{"items":132,"total":22},[],{"items":134,"total":24},[135,139,142,145,148,151],{"pma_number":17,"supplement_number":136,"trade_name":137,"applicant":138,"decision_date":118},"S005","SCOLITRON(TM) STIMULATOR","Ebi, L.P.",{"pma_number":17,"supplement_number":140,"trade_name":137,"applicant":138,"decision_date":141},"S004","1987-01-07",{"pma_number":17,"supplement_number":143,"trade_name":137,"applicant":138,"decision_date":144},"S003","1986-09-12",{"pma_number":17,"supplement_number":146,"trade_name":137,"applicant":138,"decision_date":147},"S002","1986-01-17",{"pma_number":17,"supplement_number":149,"trade_name":137,"applicant":138,"decision_date":150},"S001","1983-06-14",{"pma_number":17,"supplement_number":9,"trade_name":137,"applicant":138,"decision_date":152},"1983-01-06"]