[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NXE":3},{"classification":4,"mappedDevices":38,"similarCandidates":39,"relatedClassifications":119,"syncDates":124},{"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":32,"updated_at":33,"recall_count":34,"latest_recall_date":35,"k510_count":36,"pma_count":34,"event_count":37},1831,"NXE","Walker, Mechanical, Poly Vinyl Chloride (Pvc)","1","890.3825","PM","Physical Medicine","4","This type of mechanical walker is a four-legged device with a poly vinyl chloride (pvc) frame intended for medical purposes to provide moderate weight support while walking.  It is used by disabled persons who lack strength, good balance, or endurance.",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":28,"device_class":8,"implant_flag":29,"product_code":6,"review_panel":10,"gmp_exempt_flag":30,"third_party_flag":29,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":28,"life_sustain_support_flag":29,"medical_specialty_description":11,"summary_malfunction_reporting":31},{"k_number":18,"fei_number":20,"registration_number":27},[19],"K053192",[21,22,23,24,25,26],"3010394125","3004499949","3016159374","3003772414","3007218972","3007518294",[21,22,23,24,25,26],"","N","Y","Eligible","2026-08-18T05:52:49.347546+00:00","2026-08-18T22:05:38.961415+00:00",0,null,1,11,[],[40,49,58,65,73,81,90,96,104,112],{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":46,"vector_similarity":47,"score":48},194,"機械式人工心臓弁","Ⅳ","35590010",0.19403,0.182073,0.618789,0.0297095,{"medical_device_id":50,"generic_name":51,"class_classification":52,"jmdn_code":53,"name_similarity":54,"definition_similarity":55,"vector_similarity":56,"score":57},3329,"機械式聴診器","Ⅰ","13755000",0.207547,0.225627,0.579041,0.0163934,{"medical_device_id":59,"generic_name":60,"class_classification":52,"jmdn_code":61,"name_similarity":62,"definition_similarity":63,"vector_similarity":64,"score":57},3889,"物理療法台","13964000",0.0677966,0.212919,0.640659,{"medical_device_id":66,"generic_name":67,"class_classification":43,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},195,"人工血管付機械式人工心臓弁","35590020",0.202703,0.191214,0.599747,0.016129,{"medical_device_id":74,"generic_name":75,"class_classification":76,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":72},2517,"能動型展伸・屈伸回転運動装置","Ⅱ","70611000",0.0121951,0.179856,0.640635,{"medical_device_id":82,"generic_name":83,"class_classification":84,"jmdn_code":85,"name_similarity":86,"definition_similarity":87,"vector_similarity":88,"score":89},621,"骨スペーサ","Ⅲ","33982003",0.0377358,0.19398,0.640344,0.015873,{"medical_device_id":91,"generic_name":92,"class_classification":84,"jmdn_code":93,"name_similarity":45,"definition_similarity":94,"vector_similarity":95,"score":89},936,"機械振動電気手術器","36273000",0.212707,0.558801,{"medical_device_id":97,"generic_name":98,"class_classification":52,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":103},3961,"非能動型展伸・屈伸回転運動装置","70610000",0.0117647,0.195122,0.633464,0.015625,{"medical_device_id":105,"generic_name":106,"class_classification":84,"jmdn_code":107,"name_similarity":108,"definition_similarity":109,"vector_similarity":110,"score":111},486,"ポリビニリデンフルオライド縫合糸","38873000",0.183333,0.197917,0.568126,0.0153846,{"medical_device_id":113,"generic_name":114,"class_classification":76,"jmdn_code":115,"name_similarity":116,"definition_similarity":117,"vector_similarity":118,"score":111},2522,"能動型下肢用他動運動訓練装置","35977002",0.037037,0.144981,0.624633,[120],{"product_code":121,"device_name":122,"device_class":8,"k510_count":123},"ITJ","Walker, Mechanical",14,{"510k":125,"classification":126,"enforcement":127,"event":128,"pma":129,"warning_letter":130},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-19T04:07:02.603+00:00"]