[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KQW":3},{"classification":4,"mappedDevices":147,"similarCandidates":148,"relatedClassifications":218,"syncDates":223,"translation":230,"marketSummary":236,"recalls":255,"k510s":257,"pmas":302},{"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":141,"updated_at":142,"recall_count":143,"latest_recall_date":144,"k510_count":145,"pma_count":143,"event_count":146},2680,"KQW","Goniometer, Nonpowered","1","888.1520","OR","Orthopedic","NE","4","",false,{"openfda":17,"definition":14,"device_name":7,"review_code":14,"device_class":8,"implant_flag":139,"product_code":6,"review_panel":12,"gmp_exempt_flag":139,"third_party_flag":139,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":14,"life_sustain_support_flag":139,"medical_specialty_description":11,"summary_malfunction_reporting":140},{"k_number":18,"fei_number":32,"registration_number":116},[19,20,21,22,23,24,25,26,27,28,29,30,31],"K850082","K812778","K926237","K801716","K801715","K870767","K801717","K901744","K760302","K801718","K760301","K810441","K831550",[33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115],"2027754","1000199976","1816267","3010536692","3012447612","3010595915","3004574120","3001642379","3008044484","1519375","3016566173","3015516266","3010303097","3009746042","1720747","3007703436","3012130008","3016050940","1526439","3016219784","3009417901","3002750084","3008770252","1000168975","3007648354","1818910","3002786339","3038503932","3000270450","3006113277","3031167704","3003697160","3009759417","3002806315","3008812560","3008782585","3006128100","3013875765","3013194153","1218386","3010097171","3027847726","3020393263","3014334038","3006509795","3004905643","3007282753","3005528784","1417592","3013846070","1000518604","3004941235","3005809810","1833053","3013473968","3006076154","3002808043","2084126","3010581156","1825034","1000124207","3003423103","3009749942","1219655","1020279","3015099260","3003418325","3002854251","1421101","3005233524","3011497622","2916714","2434008","3003499359","1000115048","1221934","3035708926","3034676720","3012243493","3004216008","3014256373","3015802419","3004526603",[33,35,36,37,117,38,118,119,41,42,43,44,45,46,47,48,120,49,50,51,52,53,55,121,57,58,122,60,61,62,63,123,124,65,125,67,69,70,71,72,73,74,75,126,76,127,78,128,129,80,81,82,84,85,130,86,87,90,131,92,94,95,96,97,98,132,99,133,134,135,101,103,104,105,136,137,138,108,109,110,113,114,115],"8010379","1835998","9613350","3007366790","9610612","2087382","8040278","9611274","2939821","2531475","9613910","9710514","1836161","9616671","1421879","8040255","8010547","2432177","2249529","9616086","8030607","9611112","N","Eligible","2026-08-18T05:52:50.495594+00:00","2026-08-24T02:00:49.169481+00:00",0,null,13,4,[],[149,157,164,171,177,183,189,197,205,211],{"medical_device_id":150,"generic_name":151,"class_classification":152,"jmdn_code":153,"name_similarity":154,"definition_similarity":143,"vector_similarity":155,"score":156},1568,"電子式診断用スパイロメータ","Ⅱ","13680002",0.268293,0.627025,0.031545,{"medical_device_id":158,"generic_name":159,"class_classification":152,"jmdn_code":160,"name_similarity":161,"definition_similarity":143,"vector_similarity":162,"score":163},2910,"隅角鏡","11894000",0.178571,0.696648,0.0287391,{"medical_device_id":165,"generic_name":166,"class_classification":152,"jmdn_code":167,"name_similarity":168,"definition_similarity":143,"vector_similarity":169,"score":170},1602,"雑音発生オージオメータ","31939000",0.219512,0.602604,0.0278846,{"medical_device_id":172,"generic_name":173,"class_classification":152,"jmdn_code":174,"name_similarity":161,"definition_similarity":143,"vector_similarity":175,"score":176},1563,"黄疸計","70078000",0.668858,0.0274927,{"medical_device_id":178,"generic_name":179,"class_classification":152,"jmdn_code":180,"name_similarity":161,"definition_similarity":143,"vector_similarity":181,"score":182},1427,"膀胱計","11111000",0.607837,0.0256579,{"medical_device_id":184,"generic_name":185,"class_classification":152,"jmdn_code":186,"name_similarity":161,"definition_similarity":143,"vector_similarity":187,"score":188},1576,"カプノメータ","17148050",0.604163,0.024563,{"medical_device_id":190,"generic_name":191,"class_classification":192,"jmdn_code":193,"name_similarity":194,"definition_similarity":143,"vector_similarity":195,"score":196},4192,"電動式ギプスカッタ","Ⅰ","16340000",0.242424,0.465886,0.016129,{"medical_device_id":198,"generic_name":199,"class_classification":200,"jmdn_code":201,"name_similarity":202,"definition_similarity":143,"vector_similarity":203,"score":204},944,"ライン電源式焼灼器","Ⅲ","35030000",0.235294,0.498883,0.015873,{"medical_device_id":206,"generic_name":207,"class_classification":192,"jmdn_code":208,"name_similarity":209,"definition_similarity":143,"vector_similarity":210,"score":204},3965,"測定機能付自力運動訓練装置","70612000",0.132353,0.647266,{"medical_device_id":212,"generic_name":213,"class_classification":192,"jmdn_code":214,"name_similarity":215,"definition_similarity":143,"vector_similarity":216,"score":217},3374,"回転式肺活量計","70083000",0.142857,0.642305,0.015625,[219],{"product_code":220,"device_name":221,"device_class":8,"k510_count":222},"LZE","Isometer",1,{"510k":224,"classification":225,"enforcement":226,"event":227,"pma":228,"warning_letter":229},"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":231,"definition_ja":144,"commentary_ja":232,"model_name":233,"source_hash":234,"reviewed_by":144,"reviewed_at":144,"created_at":235,"updated_at":235},"非電動式ゴニオメータ","本品は動力を用いない機構により関節の可動域や角度を測定する整形外科用の器具です。米国ではクラスIに分類されており、市販前届出（510(k)）が免除される区分とされています。これは、安全性および有効性を確保するための規制上のリスクが低いと判断されている機器であることを意味します。","claude-sonnet-5","96d34dbde3651f72891a4668568531c5fca5d346a8e423284c52eb108bbddf55","2026-08-24T02:08:40.973135+00:00",{"product_code":6,"summary_ja":237,"stats":238,"stats_hash":253,"model_name":233,"created_at":254,"updated_at":254},"510(k)の累計件数は13件で、6社が参入していますが、直近5年間の届出はなく、最新の判定は1993年8月となっています。不具合報告は累計約4件で、いずれもMalfunction（不具合）であり、死亡・傷害の報告は確認されていません。主な問題としてはBreak、Device-Device Incompatibility、Mechanical Jamが挙げられています。回収については累計件数が0件で、報告は確認されていません。",{"pma":239,"k510":240,"as_of":243,"events":244,"recalls":247,"top_problems":249},{"latest":144,"originals":143,"supplements":143},{"total":145,"last5y":143,"latest":241,"applicants":242},"1993-08-02",6,"2026-08",{"death":143,"other":143,"total":146,"injury":143,"last5y":245,"malfunction":146,"latest_month":246},3,"2025-09",{"total":143,"last5y":143,"latest":144,"class_i":143,"class_ii":143,"class_iii":143,"top_root_causes":248},[],[250,251,252],"Break","Device-Device Incompatibility","Mechanical Jam","5ab90d3e75e82a1a8d9d08d1bec7eb1fe83d168e109042976d9cdf387be714a0","2026-08-24T04:46:30.426153+00:00",{"items":256,"total":143},[],{"items":258,"total":145},[259,265,269,273,277,281,285,288,291,293,295,297,300],{"k_number":21,"device_name":260,"applicant":261,"decision_date":241,"clearance_type":262,"decision_code":263,"statement_or_summary":264},"O'BRIEN GONIOMETER","Sgarlato Laboratories, Inc.","Traditional","SESE","Statement",{"k_number":26,"device_name":266,"applicant":267,"decision_date":268,"clearance_type":262,"decision_code":263,"statement_or_summary":144},"DOBBHOFF(R) RETRIEVAL FORCEPS","Biosearch Medical Products, Inc.","1990-07-03",{"k_number":24,"device_name":270,"applicant":271,"decision_date":272,"clearance_type":262,"decision_code":263,"statement_or_summary":144},"THE (CROM) TESTER","Twin City Surgical, Inc.","1987-03-17",{"k_number":19,"device_name":274,"applicant":275,"decision_date":276,"clearance_type":262,"decision_code":263,"statement_or_summary":144},"HAND HELD GONIOMETER","Chattanooga Group, Inc.","1985-04-04",{"k_number":31,"device_name":278,"applicant":279,"decision_date":280,"clearance_type":262,"decision_code":263,"statement_or_summary":144},"FINGER BONIOMETER BK7506","Fred Sammons, Inc.","1983-06-24",{"k_number":20,"device_name":282,"applicant":283,"decision_date":284,"clearance_type":262,"decision_code":263,"statement_or_summary":144},"THE TELOS EQUIPMENT","The Telos Co.","1981-12-08",{"k_number":30,"device_name":286,"applicant":279,"decision_date":287,"clearance_type":262,"decision_code":263,"statement_or_summary":144},"UNIVERSAL GONIMETER","1981-02-27",{"k_number":28,"device_name":289,"applicant":279,"decision_date":290,"clearance_type":262,"decision_code":263,"statement_or_summary":144},"BK-7513 STAINLESS STEEL GONIOMETER","1980-08-04",{"k_number":25,"device_name":292,"applicant":279,"decision_date":290,"clearance_type":262,"decision_code":263,"statement_or_summary":144},"BK-7511 BRASS GONIOMETER",{"k_number":22,"device_name":294,"applicant":279,"decision_date":290,"clearance_type":262,"decision_code":263,"statement_or_summary":144},"BK-7505 RADIOPAQUE GONIOMETER, 8",{"k_number":23,"device_name":296,"applicant":279,"decision_date":290,"clearance_type":262,"decision_code":263,"statement_or_summary":144},"BK-7497 BULB DYNAMOMETER",{"k_number":27,"device_name":298,"applicant":279,"decision_date":299,"clearance_type":262,"decision_code":263,"statement_or_summary":144},"GONIOMETER, INTER. STAND. LARGE, BK7514","1976-09-08",{"k_number":29,"device_name":301,"applicant":279,"decision_date":299,"clearance_type":262,"decision_code":263,"statement_or_summary":144},"GONIOMETER, MED. INTER. STAND. BK-7512",{"items":303,"total":143},[]]