[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QDT":3},{"classification":4,"mappedDevices":38,"similarCandidates":39,"relatedClassifications":119,"syncDates":170,"translation":177,"marketSummary":184,"recalls":197,"k510s":199,"pmas":207},{"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":15,"raw":16,"created_at":33,"updated_at":34,"recall_count":35,"latest_recall_date":36,"k510_count":37,"pma_count":35,"event_count":35},5364,"QDT","Shoe With Adjustable Sole Units","1","890.3475","PM","Physical Medicine","4","Intended to adjust the foots points of contact with the ground to affect the distribution of weight\u002Fforce(s) applied to a lower limb",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":29,"device_class":8,"implant_flag":30,"product_code":6,"review_panel":10,"gmp_exempt_flag":31,"third_party_flag":30,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":29,"life_sustain_support_flag":30,"medical_specialty_description":11,"summary_malfunction_reporting":32},{"k_number":18,"fei_number":20,"registration_number":28},[19],"K182090",[21,22,23,24,25,26,27],"3029745680","3024753135","3031027442","3004784464","3035878914","3033858295","3011404939",[21,22,23,24,25,26,27],"","N","Y","Ineligible","2026-08-18T05:52:52.566809+00:00","2026-08-24T02:00:49.029844+00:00",0,null,1,[],[40,49,56,65,72,80,87,96,103,112],{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":46,"vector_similarity":47,"score":48},3962,"非能動型自動牽引装置","Ⅰ","14105001",0.0892857,0.160458,0.663918,0.0163934,{"medical_device_id":50,"generic_name":51,"class_classification":43,"jmdn_code":52,"name_similarity":53,"definition_similarity":54,"vector_similarity":55,"score":48},3985,"電気手術器用ケーブル及びスイッチ","70657000",0.189655,0.158996,0.510135,{"medical_device_id":57,"generic_name":58,"class_classification":59,"jmdn_code":60,"name_similarity":61,"definition_similarity":62,"vector_similarity":63,"score":64},2518,"能動型自動牽引装置","Ⅱ","14105002",0.0943396,0.191011,0.662534,0.016129,{"medical_device_id":66,"generic_name":67,"class_classification":59,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":64},2624,"可搬式歯科用ユニット","70725000",0.186047,0.180905,0.454028,{"medical_device_id":73,"generic_name":74,"class_classification":59,"jmdn_code":75,"name_similarity":76,"definition_similarity":77,"vector_similarity":78,"score":79},2308,"可搬型吸引器","36616009",0.1875,0.113475,0.547592,0.015873,{"medical_device_id":81,"generic_name":82,"class_classification":59,"jmdn_code":83,"name_similarity":84,"definition_similarity":85,"vector_similarity":86,"score":79},2519,"能動型自動間欠牽引装置","14106002",0.0757576,0.170213,0.636412,{"medical_device_id":88,"generic_name":89,"class_classification":90,"jmdn_code":91,"name_similarity":92,"definition_similarity":93,"vector_similarity":94,"score":95},144,"ウロキナーゼ使用体内植込み用カテーテル","Ⅳ","70386000",0.178571,0.163717,0.446697,0.015625,{"medical_device_id":97,"generic_name":98,"class_classification":59,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":95},2540,"手足治療ユニット","37212000",0.0784314,0.1625,0.631743,{"medical_device_id":104,"generic_name":105,"class_classification":106,"jmdn_code":107,"name_similarity":108,"definition_similarity":109,"vector_similarity":110,"score":111},958,"再使用可能なフットコントロール式電気手術器用アクティブ電極","Ⅲ","42553000",0.103896,0.166154,0.630962,0.0153846,{"medical_device_id":113,"generic_name":114,"class_classification":59,"jmdn_code":115,"name_similarity":116,"definition_similarity":117,"vector_similarity":118,"score":111},2625,"可搬式歯科用オプション追加型ユニット","70726000",0.172414,0.116279,0.500727,[120,124,128,132,136,140,144,148,152,155,158,161,164,167],{"product_code":121,"device_name":122,"device_class":8,"k510_count":123},"IQI","Orthosis, Limb Brace",52,{"product_code":125,"device_name":126,"device_class":8,"k510_count":127},"ILH","Splint, Hand, And Components",36,{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"ITQ","Joint, Knee, External Brace",15,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"ILG","Stocking, Elastic",8,{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"KNP","Orthosis, Corrective Shoe",7,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"ITM","Cage, Knee",5,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"ILE","Sling, Arm, Overhead Supported",3,{"product_code":149,"device_name":150,"device_class":8,"k510_count":151},"LQX","Device, Finger-Sucking",2,{"product_code":153,"device_name":154,"device_class":8,"k510_count":151},"MNE","Orthosis, Moldable, Supportive, Skin Protective",{"product_code":156,"device_name":157,"device_class":8,"k510_count":37},"IOY","Support, Arm",{"product_code":159,"device_name":160,"device_class":8,"k510_count":37},"ITS","Joint, Hip, External Brace",{"product_code":162,"device_name":163,"device_class":8,"k510_count":37},"ITW","Joint, Ankle, External Brace",{"product_code":165,"device_name":166,"device_class":8,"k510_count":37},"OHI","Orthosis, Foot Drop",{"product_code":168,"device_name":169,"device_class":8,"k510_count":37},"PMV","Orthosis, Limb, For Back Pain",{"510k":171,"classification":172,"enforcement":173,"event":174,"pma":175,"warning_letter":176},"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":178,"definition_ja":179,"commentary_ja":180,"model_name":181,"source_hash":182,"reviewed_by":36,"reviewed_at":36,"created_at":183,"updated_at":183},"調整可能靴底装具","下肢に加わる体重／力の分布に影響を与えるため、足の接地点を調整することを目的とする。","本機器は米国においてクラスIに分類されており、市販前届出（510(k)）が免除される区分に該当します。クラスIは一般に安全性のリスクが低い機器に適用され、有効性や安全性を個別に審査する510(k)やPMAの手続きを経ずに市販することが可能です。","claude-sonnet-5","72a3360070b9f7112abab8c12f05f3698858a1b3ad2c043e00383009b4a2cc19","2026-08-24T02:37:21.239845+00:00",{"product_code":6,"summary_ja":185,"stats":186,"stats_hash":195,"model_name":181,"created_at":196,"updated_at":196},"本製品は届出免除区分であり、510(k)は累計1件の実績が確認されていますが、直近5年間の届出はありません。不具合報告および回収については、いずれも累計0件であり、確認されていません。",{"pma":187,"k510":188,"as_of":190,"events":191,"recalls":192,"top_problems":194},{"latest":36,"originals":35,"supplements":35},{"total":37,"last5y":35,"latest":189,"applicants":37},"2018-11-16","2026-08",{"death":35,"other":35,"total":35,"injury":35,"last5y":35,"malfunction":35,"latest_month":36},{"total":35,"last5y":35,"latest":36,"class_i":35,"class_ii":35,"class_iii":35,"top_root_causes":193},[],[],"93e81c928a10aed68c1846d439f8d0f92ecfad6253bd04dbf616b4f91f7a1848","2026-08-24T05:16:12.270965+00:00",{"items":198,"total":35},[],{"items":200,"total":37},[201],{"k_number":19,"device_name":202,"applicant":203,"decision_date":189,"clearance_type":204,"decision_code":205,"statement_or_summary":206},"AposTherapy System","Apos Medical Assets , Ltd.","Traditional","SESE","Summary",{"items":208,"total":35},[]]