[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KTH":3},{"classification":4,"mappedDevices":37,"similarCandidates":38,"relatedClassifications":107,"syncDates":108,"translation":115,"marketSummary":121,"recalls":134,"k510s":136,"pmas":156},{"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":32,"updated_at":33,"recall_count":34,"latest_recall_date":35,"k510_count":36,"pma_count":34,"event_count":34},5984,"KTH","Device, Anti-Stammering","1","874.5840","EN","Ear, Nose, Throat","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":30,"product_code":6,"review_panel":10,"gmp_exempt_flag":30,"third_party_flag":30,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":30,"medical_specialty_description":11,"summary_malfunction_reporting":31},{"k_number":17,"fei_number":22,"registration_number":28},[18,19,20,21],"K942651","K800445","K962961","K871590",[23,24,25,26,27],"3007694978","3015259858","3010550507","1044692","3003387922",[23,24,25,29,26],"1066749","N","Eligible","2026-08-18T05:52:52.949882+00:00","2026-08-24T02:00:47.513022+00:00",0,null,4,[],[39,47,54,62,68,76,81,88,94,101],{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":34,"vector_similarity":45,"score":46},647,"人工内耳","Ⅲ","35643000",0.06,0.664348,0.0163934,{"medical_device_id":48,"generic_name":49,"class_classification":50,"jmdn_code":51,"name_similarity":52,"definition_similarity":34,"vector_similarity":53,"score":46},3588,"自動染色装置","Ⅰ","70191000",0.361111,0.517736,{"medical_device_id":55,"generic_name":56,"class_classification":57,"jmdn_code":58,"name_similarity":59,"definition_similarity":34,"vector_similarity":60,"score":61},1456,"聴覚誘発反応刺激装置","Ⅱ","35368000",0.0545455,0.655538,0.016129,{"medical_device_id":63,"generic_name":64,"class_classification":50,"jmdn_code":65,"name_similarity":66,"definition_similarity":34,"vector_similarity":67,"score":61},3766,"内視鏡処置用縫合器","34078000",0.275,0.498889,{"medical_device_id":69,"generic_name":70,"class_classification":71,"jmdn_code":72,"name_similarity":73,"definition_similarity":34,"vector_similarity":74,"score":75},253,"強膜バックリング用器具","Ⅳ","15794000",0.27027,0.555424,0.015873,{"medical_device_id":77,"generic_name":78,"class_classification":57,"jmdn_code":79,"name_similarity":34,"definition_similarity":34,"vector_similarity":80,"score":75},2977,"耳鳴マスカ","30899000",0.641142,{"medical_device_id":82,"generic_name":83,"class_classification":71,"jmdn_code":84,"name_similarity":85,"definition_similarity":34,"vector_similarity":86,"score":87},293,"発作防止用脳電気刺激装置","36222000",0.105263,0.639329,0.015625,{"medical_device_id":89,"generic_name":90,"class_classification":57,"jmdn_code":91,"name_similarity":92,"definition_similarity":34,"vector_similarity":93,"score":87},2305,"気道粘液除去装置","43947000",0.268293,0.567736,{"medical_device_id":95,"generic_name":96,"class_classification":57,"jmdn_code":97,"name_similarity":98,"definition_similarity":34,"vector_similarity":99,"score":100},1457,"胎児聴覚誘発反応刺激装置","36159000",0.0491803,0.632581,0.0153846,{"medical_device_id":102,"generic_name":103,"class_classification":57,"jmdn_code":104,"name_similarity":105,"definition_similarity":34,"vector_similarity":106,"score":100},2215,"単回使用自動縫合器","15065002",0.26087,0.496694,[],{"510k":109,"classification":110,"enforcement":111,"event":112,"pma":113,"warning_letter":114},"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":116,"definition_ja":35,"commentary_ja":117,"model_name":118,"source_hash":119,"reviewed_by":35,"reviewed_at":35,"created_at":120,"updated_at":120},"吃音矯正器","本品は米国FDAの規制上、クラスIに分類される医療機器です。クラスIは相対的にリスクが低い機器であり、本品は510(k)による市販前届出が免除されており、市販前の届出手続きを経ずに販売することが可能です。","claude-sonnet-5","a87aa5fbb68b847ad68b7f9900eb101a45cb5f085862f2c8366fca81fe40b87e","2026-08-24T02:08:40.973135+00:00",{"product_code":6,"summary_ja":122,"stats":123,"stats_hash":132,"model_name":118,"created_at":133,"updated_at":133},"本製品は510(k)届出免除の対象であり、510(k)は累計4件、参入企業数は4社となっていますが、直近5年間の届出はなく最新の判定は1996年9月です。PMAの承認実績は確認されていません。不具合報告および回収については、いずれも累計件数が0件であり、報告・実施の実績は確認されていません。",{"pma":124,"k510":125,"as_of":127,"events":128,"recalls":129,"top_problems":131},{"latest":35,"originals":34,"supplements":34},{"total":36,"last5y":34,"latest":126,"applicants":36},"1996-09-09","2026-08",{"death":34,"other":34,"total":34,"injury":34,"last5y":34,"malfunction":34,"latest_month":35},{"total":34,"last5y":34,"latest":35,"class_i":34,"class_ii":34,"class_iii":34,"top_root_causes":130},[],[],"18ebc6acd3d33c6b237b9982ee4e07c7e6e933c1bc187a22fdd5e1023c4a6be6","2026-08-24T04:46:30.426153+00:00",{"items":135,"total":34},[],{"items":137,"total":36},[138,144,148,152],{"k_number":20,"device_name":139,"applicant":140,"decision_date":126,"clearance_type":141,"decision_code":142,"statement_or_summary":143},"SUSTAINED PHONATION","Surface Mount Technology, Inc.","Traditional","SESE","Statement",{"k_number":18,"device_name":145,"applicant":146,"decision_date":147,"clearance_type":141,"decision_code":142,"statement_or_summary":143},"BIOFEEDBACK  SYSTEM FOR SPEECH DISORDERS","Casa Futura Technologies","1995-10-19",{"k_number":21,"device_name":149,"applicant":150,"decision_date":151,"clearance_type":141,"decision_code":142,"statement_or_summary":35},"VOCALTECH VOCAL FEEDBACK DEVICE","Vocaltech C\u002FO Hogan & Hartson","1987-10-06",{"k_number":19,"device_name":153,"applicant":154,"decision_date":155,"clearance_type":141,"decision_code":142,"statement_or_summary":35},"EDINBURGH MASKER","Foundation For Fluency, Inc.","1980-03-12",{"items":157,"total":34},[]]