[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-SFJ":3},{"classification":4,"mappedDevices":34,"similarCandidates":35,"relatedClassifications":117,"syncDates":118,"translation":125,"marketSummary":132,"recalls":147,"k510s":149,"pmas":151},{"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":28,"updated_at":29,"recall_count":30,"latest_recall_date":31,"k510_count":30,"pma_count":32,"event_count":33},3235,"SFJ","Vagus Nerve Stimulator For Rheumatoid Arthritis","3","","Unknown","NE","2","Implantable vagus nerve stimulator for Rheumatoid Arthritis",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":25,"product_code":6,"review_panel":11,"gmp_exempt_flag":26,"third_party_flag":26,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":26,"medical_specialty_description":10,"summary_malfunction_reporting":27},{"fei_number":18,"pma_number":22,"registration_number":24},[19,20,21],"3009183442","3013688988","3011235999",[23],"P240039",[19,20,21],"Y","N","Ineligible","2026-08-18T05:52:50.955415+00:00","2026-08-24T02:00:48.882786+00:00",0,null,3,1,[],[36,45,52,60,68,77,85,93,101,109],{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":42,"vector_similarity":43,"score":44},299,"抗発作用迷走神経電気刺激装置","Ⅳ","34210000",0.373134,0.130597,0.781955,0.0325225,{"medical_device_id":46,"generic_name":47,"class_classification":39,"jmdn_code":48,"name_similarity":41,"definition_similarity":49,"vector_similarity":50,"score":51},294,"昏睡覚醒用迷走神経電気刺激装置","37310000",0.172775,0.72695,0.0320184,{"medical_device_id":53,"generic_name":54,"class_classification":39,"jmdn_code":55,"name_similarity":56,"definition_similarity":57,"vector_similarity":58,"score":59},254,"植込み型迷走神経刺激電極及びリード","44041000",0.315068,0.240741,0.762168,0.0310245,{"medical_device_id":61,"generic_name":62,"class_classification":39,"jmdn_code":63,"name_similarity":64,"definition_similarity":65,"vector_similarity":66,"score":67},295,"精神療法用迷走神経電気刺激装置","37311000",0.306667,0.146199,0.768337,0.0306218,{"medical_device_id":69,"generic_name":70,"class_classification":71,"jmdn_code":72,"name_similarity":73,"definition_similarity":74,"vector_similarity":75,"score":76},1469,"顔面神経刺激装置","Ⅱ","35724000",0.346154,0.0607143,0.688612,0.0300905,{"medical_device_id":78,"generic_name":79,"class_classification":39,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":84},292,"血圧頸動脈洞枝電気刺激装置","35369000",0.279412,0.195767,0.721379,0.0294372,{"medical_device_id":86,"generic_name":87,"class_classification":39,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},1143,"舌下神経電気刺激装置","60360004",0.25,0.101504,0.715702,0.0280833,{"medical_device_id":94,"generic_name":95,"class_classification":39,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":100},321,"植込み型末梢神経無痛法用電気刺激装置","38474000",0.204545,0.110063,0.725864,0.0271493,{"medical_device_id":102,"generic_name":103,"class_classification":71,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":108},1623,"局所麻酔用神経刺激装置","37042000",0.290323,0.103448,0.665688,0.0267427,{"medical_device_id":110,"generic_name":111,"class_classification":39,"jmdn_code":112,"name_similarity":113,"definition_similarity":114,"vector_similarity":115,"score":116},6,"心臓・中枢神経刺激用プローブ","36957004",0.278689,0.164062,0.665577,0.0263889,[],{"510k":119,"classification":120,"enforcement":121,"event":122,"pma":123,"warning_letter":124},"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":126,"definition_ja":127,"commentary_ja":128,"model_name":129,"source_hash":130,"reviewed_by":31,"reviewed_at":31,"created_at":131,"updated_at":131},"関節リウマチ治療用埋込型迷走神経刺激装置","関節リウマチのための植込み型迷走神経刺激装置である。","本品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）による審査が必要とされています。クラスIIIは人の生命維持や健康に重大な影響を及ぼす可能性がある機器に適用される最も規制が厳しい区分であり、有効性および安全性に関する科学的な証拠を含む詳細な審査を経て承認される仕組みとなっています。","claude-sonnet-5","59ff0f5171843a71a05b9957e1699244b9c93482ab49b90379063cd704a64bde","2026-08-24T03:40:21.731962+00:00",{"product_code":6,"summary_ja":133,"stats":134,"stats_hash":145,"model_name":129,"created_at":146,"updated_at":146},"本製品はPMA区分で、本承認1件と一部変更承認2件が確認されており、最新の判定は2026年2月です。不具合報告は累計1件で、内容は傷害（Injury）が1件となっており、死亡や不具合（Malfunction）の報告は確認されていません。直近5年の報告件数も1件で、最新の報告月は2026年6月です。回収については累計0件であり、クラスI・II・IIIいずれも確認されていません。",{"pma":135,"k510":138,"as_of":139,"events":140,"recalls":142,"top_problems":144},{"latest":136,"originals":33,"supplements":137},"2026-02-18",2,{"total":30,"last5y":30,"latest":31,"applicants":30},"2026-08",{"death":30,"other":30,"total":33,"injury":33,"last5y":33,"malfunction":30,"latest_month":141},"2026-06",{"total":30,"last5y":30,"latest":31,"class_i":30,"class_ii":30,"class_iii":30,"top_root_causes":143},[],[],"b6072e6f29a709afcf4d19db618ea88ba923baa1bcfb237f587a51c2f7f2d8e6","2026-08-24T05:23:16.025025+00:00",{"items":148,"total":30},[],{"items":150,"total":30},[],{"items":152,"total":32},[153,157,160],{"pma_number":23,"supplement_number":154,"trade_name":155,"applicant":156,"decision_date":136},"S002","SetPoint System","SetPoint Medical",{"pma_number":23,"supplement_number":158,"trade_name":155,"applicant":156,"decision_date":159},"S001","2026-01-16",{"pma_number":23,"supplement_number":9,"trade_name":155,"applicant":156,"decision_date":161},"2025-07-30"]