[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NKI":3},{"classification":4,"mappedDevices":32,"similarCandidates":33,"relatedClassifications":114,"syncDates":120,"translation":127,"marketSummary":134,"recalls":147,"k510s":149,"pmas":157},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":27,"updated_at":28,"recall_count":29,"latest_recall_date":30,"k510_count":31,"pma_count":29,"event_count":29},914,"NKI","Goniometer With Electrodes","2","888.1500","OR","Orthopedic","NE","4","A goniometer is an AC-powered or battery powered  device intended to evaluate joint function by measuring and recording range of motion, acceleration, or forces exerted by a joint. The class II (special controls) goniometer uses transcutaneous adhesive electrode lead wires and patient cables to transmit and record patient data.",false,{"openfda":17,"definition":14,"device_name":7,"review_code":24,"device_class":8,"implant_flag":25,"product_code":6,"review_panel":12,"gmp_exempt_flag":25,"third_party_flag":25,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":24,"life_sustain_support_flag":25,"medical_specialty_description":11,"summary_malfunction_reporting":26},{"k_number":18,"fei_number":20,"registration_number":23},[19],"K033193",[21,22],"3026042200","3027475369",[21,22],"","N","Eligible","2026-08-18T05:52:48.222586+00:00","2026-08-24T02:00:47.513022+00:00",0,null,1,[],[34,43,51,59,66,74,81,89,98,106],{"medical_device_id":35,"generic_name":36,"class_classification":37,"jmdn_code":38,"name_similarity":39,"definition_similarity":40,"vector_similarity":41,"score":42},1467,"筋電計電極","Ⅱ","11441002",0.243243,0.197411,0.691022,0.0277831,{"medical_device_id":44,"generic_name":45,"class_classification":37,"jmdn_code":46,"name_similarity":47,"definition_similarity":48,"vector_similarity":49,"score":50},2996,"電子尿糖計","70188012",0.288889,0.199301,0.677084,0.0276377,{"medical_device_id":52,"generic_name":53,"class_classification":37,"jmdn_code":54,"name_similarity":55,"definition_similarity":56,"vector_similarity":57,"score":58},1627,"電気味覚計","70100000",0.363636,0.226481,0.588882,0.0163934,{"medical_device_id":60,"generic_name":61,"class_classification":37,"jmdn_code":62,"name_similarity":63,"definition_similarity":64,"vector_similarity":65,"score":58},2910,"隅角鏡","11894000",0.151515,0.0884956,0.75257,{"medical_device_id":67,"generic_name":68,"class_classification":37,"jmdn_code":69,"name_similarity":70,"definition_similarity":71,"vector_similarity":72,"score":73},1363,"電子体温計","14032010",0.351351,0.24581,0.645174,0.016129,{"medical_device_id":75,"generic_name":76,"class_classification":37,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":73},1568,"電子式診断用スパイロメータ","13680002",0.0961538,0.239264,0.737413,{"medical_device_id":82,"generic_name":83,"class_classification":37,"jmdn_code":84,"name_similarity":85,"definition_similarity":86,"vector_similarity":87,"score":88},2898,"電池電源式関節手術用器械","70964022",0.0147059,0.181132,0.729762,0.015873,{"medical_device_id":90,"generic_name":91,"class_classification":92,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":97},52,"心臓用カテーテル型電極","Ⅳ","11434100",0.272727,0.245179,0.644574,0.015625,{"medical_device_id":99,"generic_name":100,"class_classification":101,"jmdn_code":102,"name_similarity":103,"definition_similarity":104,"vector_similarity":105,"score":97},3571,"尿比重計","Ⅰ","70187000",0.128205,0.139831,0.714886,{"medical_device_id":107,"generic_name":108,"class_classification":37,"jmdn_code":109,"name_similarity":110,"definition_similarity":111,"vector_similarity":112,"score":113},1371,"医用電子血圧計","16173010",0.26,0.233696,0.641366,0.0153846,[115],{"product_code":116,"device_name":117,"device_class":118,"k510_count":119},"KQX","Goniometer, Ac-Powered","1",33,{"510k":121,"classification":122,"enforcement":123,"event":124,"pma":125,"warning_letter":126},"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":128,"definition_ja":129,"commentary_ja":130,"model_name":131,"source_hash":132,"reviewed_by":30,"reviewed_at":30,"created_at":133,"updated_at":133},"電極付関節角度計","ゴニオメータは、関節の可動域、加速度、又は関節が及ぼす力を測定及び記録することにより関節機能を評価することを目的とした、AC電源又は電池式の機器である。クラスII（特別管理）のゴニオメータは、経皮的粘着電極リード線及び患者ケーブルを使用して患者データを伝送及び記録する。","この機器は米国においてクラスIIに分類されていますが、審査区分としては510(k)の届出が免除される機器です。クラスIIは中程度のリスクを有する医療機器区分であり、通常は市販前届出（510(k)）が求められますが、本品については特別管理（special controls）の下で届出が免除されています。","claude-sonnet-5","4b10cf5db09d2c5f268378a085b5034c2e19d8e0cd54d661da9e44ea96723592","2026-08-24T02:18:13.311568+00:00",{"product_code":6,"summary_ja":135,"stats":136,"stats_hash":145,"model_name":131,"created_at":146,"updated_at":146},"本製品区分では、510(k)の累計件数は1件、参入企業数は1社で、直近5年間の届出実績は確認されていません。不具合報告（MDR）については累計報告件数が0件であり、報告事例は確認されていません。回収についても累計件数は0件で、該当する実績は確認されていません。",{"pma":137,"k510":138,"as_of":140,"events":141,"recalls":142,"top_problems":144},{"latest":30,"originals":29,"supplements":29},{"total":31,"last5y":29,"latest":139,"applicants":31},"2004-01-23","2026-08",{"death":29,"other":29,"total":29,"injury":29,"last5y":29,"malfunction":29,"latest_month":30},{"total":29,"last5y":29,"latest":30,"class_i":29,"class_ii":29,"class_iii":29,"top_root_causes":143},[],[],"9e8e90ed52cf35f212c2adff19d7c4b6769c281b88d4fd74074c55251082b30a","2026-08-24T04:59:09.208125+00:00",{"items":148,"total":29},[],{"items":150,"total":31},[151],{"k_number":19,"device_name":152,"applicant":153,"decision_date":139,"clearance_type":154,"decision_code":155,"statement_or_summary":156},"SONOSENS","Friendly Sensors AG","Abbreviated","SESE","Summary",{"items":158,"total":29},[]]