[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QKI":3},{"classification":4,"mappedDevices":36,"similarCandidates":37,"relatedClassifications":117,"syncDates":122},{"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":14,"raw":15,"created_at":33,"updated_at":33,"recall_count":34,"latest_recall_date":35,"k510_count":34,"pma_count":34,"event_count":34},7,"QKI","Media, Reproductive, Exempt","2","884.6180","OB","Obstetrics\u002FGynecology","4","This product code is the class II exempt counterpart of MQL, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":30,"device_class":8,"implant_flag":31,"product_code":6,"review_panel":10,"gmp_exempt_flag":31,"third_party_flag":31,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":30,"life_sustain_support_flag":31,"medical_specialty_description":11,"summary_malfunction_reporting":32},{"fei_number":17,"registration_number":29},[18,19,20,21,22,23,24,25,26,27,28],"3003274090","3016214552","1221433","3025773437","3021166069","3003995932","3016126174","3003272500","3015140190","3008876063","3030541196",[18,19,20,21,22,23,24,25,26,27,28],"","N","Ineligible","2026-08-18T05:52:47.660896+00:00",0,null,[],[38,47,56,63,71,78,86,93,102,109],{"medical_device_id":39,"generic_name":40,"class_classification":41,"jmdn_code":42,"name_similarity":43,"definition_similarity":44,"vector_similarity":45,"score":46},4366,"医療用拡張器","Ⅰ","70969001",0.133333,0.132075,0.539165,0.025487,{"medical_device_id":48,"generic_name":49,"class_classification":50,"jmdn_code":51,"name_similarity":52,"definition_similarity":53,"vector_similarity":54,"score":55},2404,"再使用可能な間欠的強制換気補助人工呼吸器呼吸回路","Ⅱ","42909000",0.0263158,0.193989,0.583739,0.0163934,{"medical_device_id":57,"generic_name":58,"class_classification":50,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":55},2524,"能動型呼吸運動訓練装置","11634002",0.195652,0.148515,0.428536,{"medical_device_id":64,"generic_name":65,"class_classification":50,"jmdn_code":66,"name_similarity":67,"definition_similarity":68,"vector_similarity":69,"score":70},2944,"低周波・温灸組合せ家庭用医療機器","70999000",0.05,0.0819113,0.580818,0.016129,{"medical_device_id":72,"generic_name":73,"class_classification":41,"jmdn_code":74,"name_similarity":75,"definition_similarity":76,"vector_similarity":77,"score":70},3969,"非能動型呼吸運動訓練装置","11634001",0.18,0.116667,0.429944,{"medical_device_id":79,"generic_name":80,"class_classification":50,"jmdn_code":81,"name_similarity":82,"definition_similarity":83,"vector_similarity":84,"score":85},2521,"能動型手用他動運動訓練装置","17137002",0.150943,0.122977,0.414356,0.015873,{"medical_device_id":87,"generic_name":88,"class_classification":50,"jmdn_code":89,"name_similarity":90,"definition_similarity":91,"vector_similarity":92,"score":85},2943,"低周波・温熱組合せ家庭用医療機器","70998000",0.0547945,0.0678571,0.576338,{"medical_device_id":94,"generic_name":95,"class_classification":96,"jmdn_code":97,"name_similarity":98,"definition_similarity":99,"vector_similarity":100,"score":101},1161,"再製造心臓用カテーテル型電極","Ⅳ","46359004",0.135593,0.205446,0.436612,0.015625,{"medical_device_id":103,"generic_name":104,"class_classification":50,"jmdn_code":105,"name_similarity":106,"definition_similarity":107,"vector_similarity":108,"score":101},2939,"低周波・温熱・電気マッサージ組合せ家庭用医療機器","70994000",0.0574713,0.0821918,0.5684,{"medical_device_id":110,"generic_name":111,"class_classification":50,"jmdn_code":112,"name_similarity":113,"definition_similarity":114,"vector_similarity":115,"score":116},1742,"硬性縦隔鏡","35187000",0.142857,0.148338,0.458461,0.0153846,[118],{"product_code":119,"device_name":120,"device_class":8,"k510_count":121},"MQL","Media, Reproductive",259,{"510k":123,"classification":124,"enforcement":125,"event":126,"pma":127,"warning_letter":128},"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","2026-08-18T06:42:29.411+00:00"]