[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NBN":3},{"classification":4,"mappedDevices":48,"similarCandidates":49,"relatedClassifications":122,"syncDates":123,"translation":130,"marketSummary":136,"recalls":154,"k510s":156,"pmas":158},{"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":42,"updated_at":43,"recall_count":44,"latest_recall_date":45,"k510_count":44,"pma_count":46,"event_count":47},7043,"NBN","Generator, Shock-Wave, For Pain Relief","3","","Unknown","OR","2",false,{"openfda":15,"definition":9,"device_name":7,"review_code":9,"device_class":8,"implant_flag":40,"product_code":6,"review_panel":11,"gmp_exempt_flag":40,"third_party_flag":40,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":40,"medical_specialty_description":10,"summary_malfunction_reporting":41},{"fei_number":16,"pma_number":25,"registration_number":33},[17,18,19,20,21,22,23,24],"2020737","3002808188","3004096429","3006261799","3000205943","3002807616","3002806910","1000511585",[26,27,28,29,30,31,32],"P990086","P050004","P080028","P040026","P000048","P040039","P010039",[34,35,36,19,37,38,22,39],"8030987","9613347","1061158","3012446970","1062240","1648564","N","Eligible","2026-08-18T05:52:53.878886+00:00","2026-08-24T02:00:48.366308+00:00",0,null,15,10,[],[50,58,66,73,80,87,94,101,108,115],{"medical_device_id":51,"generic_name":52,"class_classification":53,"jmdn_code":54,"name_similarity":55,"definition_similarity":44,"vector_similarity":56,"score":57},1066,"体外衝撃波疼痛治療装置","Ⅲ","71029000",0.188406,0.744105,0.0310993,{"medical_device_id":59,"generic_name":60,"class_classification":61,"jmdn_code":62,"name_similarity":63,"definition_similarity":44,"vector_similarity":64,"score":65},305,"植込み型疼痛緩和用スティミュレータ","Ⅳ","70600000",0.345455,0.677823,0.0308862,{"medical_device_id":67,"generic_name":68,"class_classification":53,"jmdn_code":69,"name_similarity":70,"definition_similarity":44,"vector_similarity":71,"score":72},972,"高周波病変ジェネレータ","35156000",0.210526,0.656074,0.0285312,{"medical_device_id":74,"generic_name":75,"class_classification":53,"jmdn_code":76,"name_similarity":77,"definition_similarity":44,"vector_similarity":78,"score":79},979,"体内式衝撃波結石破砕装置","70673000",0.171875,0.677908,0.0276929,{"medical_device_id":81,"generic_name":82,"class_classification":53,"jmdn_code":83,"name_similarity":84,"definition_similarity":44,"vector_similarity":85,"score":86},770,"汎用人工呼吸器","70561000",0.245283,0.474056,0.016129,{"medical_device_id":88,"generic_name":89,"class_classification":90,"jmdn_code":91,"name_similarity":92,"definition_similarity":44,"vector_similarity":93,"score":86},1629,"電動式皮膚痛覚計","Ⅱ","12950002",0.103448,0.691935,{"medical_device_id":95,"generic_name":96,"class_classification":53,"jmdn_code":97,"name_similarity":98,"definition_similarity":44,"vector_similarity":99,"score":100},830,"電動式心肺人工蘇生器","35309000",0.0895522,0.684468,0.015873,{"medical_device_id":102,"generic_name":103,"class_classification":90,"jmdn_code":104,"name_similarity":105,"definition_similarity":44,"vector_similarity":106,"score":107},2471,"低周波治療器","35372000",0.0307692,0.683651,0.015625,{"medical_device_id":109,"generic_name":110,"class_classification":111,"jmdn_code":112,"name_similarity":113,"definition_similarity":44,"vector_similarity":114,"score":107},3721,"再使用可能な一般静脈用翼付針","Ⅰ","70377000",0.206349,0.477226,{"medical_device_id":116,"generic_name":117,"class_classification":61,"jmdn_code":118,"name_similarity":119,"definition_similarity":44,"vector_similarity":120,"score":121},272,"除細動機能付植込み型両心室ペーシングパルスジェネレータ","70514000",0.142857,0.681629,0.0153846,[],{"510k":124,"classification":125,"enforcement":126,"event":127,"pma":128,"warning_letter":129},"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":131,"definition_ja":45,"commentary_ja":132,"model_name":133,"source_hash":134,"reviewed_by":45,"reviewed_at":45,"created_at":135,"updated_at":135},"疼痛緩和用衝撃波発生装置","この機器は、疼痛緩和を目的として衝撃波を発生させる装置です。米国ではクラスIIIに分類されており、市販に際しては市販前届出（510(k)）よりも厳格な市販前承認（PMA）による審査を経て、安全性及び有効性を科学的根拠に基づいて示すことが求められます。","claude-sonnet-5","6ed6d83251eed97d17f414424acee846f83df4110fc0d75d3b247e94bd5c9998","2026-08-24T02:15:50.744711+00:00",{"product_code":6,"summary_ja":137,"stats":138,"stats_hash":152,"model_name":133,"created_at":153,"updated_at":153},"本製品はPMA（市販前承認）区分で、本承認が約7件、一部変更承認が約8件あり、直近の判定は2020年2月となっています。不具合報告は累計約10件で、死亡報告は確認されておらず、傷害が約7件、不具合（Malfunction）が約3件と傷害の報告が大半を占めています。回収（リコール）の報告は確認されていません。",{"pma":139,"k510":143,"as_of":144,"events":145,"recalls":149,"top_problems":151},{"latest":140,"originals":141,"supplements":142},"2020-02-05",7,8,{"total":44,"last5y":44,"latest":45,"applicants":44},"2026-08",{"death":44,"other":44,"total":47,"injury":141,"last5y":146,"malfunction":147,"latest_month":148},1,3,"2025-01",{"total":44,"last5y":44,"latest":45,"class_i":44,"class_ii":44,"class_iii":44,"top_root_causes":150},[],[],"12997a1bd88b4ec50fc64e596e3f12131e506862ebaafbeefc54ccfe8315ca21","2026-08-24T04:57:04.90455+00:00",{"items":155,"total":44},[],{"items":157,"total":44},[],{"items":159,"total":46},[160,164,167,171,174,179,183,187,192,196,198,201,205,207,209],{"pma_number":28,"supplement_number":161,"trade_name":162,"applicant":163,"decision_date":140},"S001","Storz Medical Duolith SD1 Shock Wave Therapy Device","Storz Medical AG",{"pma_number":28,"supplement_number":9,"trade_name":165,"applicant":163,"decision_date":166},"STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY","2016-01-08",{"pma_number":27,"supplement_number":161,"trade_name":168,"applicant":169,"decision_date":170},"EMS-SWISS DOLORCLAST","Electro Medical Systems (Ems Sa)","2009-08-28",{"pma_number":27,"supplement_number":9,"trade_name":172,"applicant":169,"decision_date":173},"EMS SWISS DOLORCLAST","2007-05-08",{"pma_number":32,"supplement_number":175,"trade_name":176,"applicant":177,"decision_date":178},"S003","SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT)","Siemens Medical Solutions USA, Inc.","2005-09-27",{"pma_number":31,"supplement_number":9,"trade_name":180,"applicant":181,"decision_date":182},"ORBASONE PAIN RELIEF SYSTEM","Orthometrix, Inc.","2005-08-10",{"pma_number":29,"supplement_number":9,"trade_name":184,"applicant":185,"decision_date":186},"ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE","Medispec, Ltd.","2005-04-01",{"pma_number":26,"supplement_number":188,"trade_name":189,"applicant":190,"decision_date":191},"S004","HEALTHTRONICS OSSATRON","Sanuwave, Inc.","2004-08-06",{"pma_number":32,"supplement_number":193,"trade_name":194,"applicant":177,"decision_date":195},"S002","SIEMENS SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) SYSTEM","2003-04-03",{"pma_number":26,"supplement_number":175,"trade_name":189,"applicant":190,"decision_date":197},"2003-03-14",{"pma_number":32,"supplement_number":9,"trade_name":199,"applicant":177,"decision_date":200},"SIEMENS SONOCUR BASIC SYSTEM","2002-07-19",{"pma_number":30,"supplement_number":9,"trade_name":202,"applicant":203,"decision_date":204},"DORNIER EPOS ULTRA","Dornier Medtech America, Inc.","2002-01-15",{"pma_number":26,"supplement_number":161,"trade_name":189,"applicant":190,"decision_date":206},"2001-05-01",{"pma_number":26,"supplement_number":193,"trade_name":189,"applicant":190,"decision_date":208},"2001-03-30",{"pma_number":26,"supplement_number":9,"trade_name":189,"applicant":190,"decision_date":210},"2000-10-12"]