[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-RGI":3},{"classification":4,"mappedDevices":22,"similarCandidates":23,"relatedClassifications":103,"syncDates":104,"translation":111,"marketSummary":118,"recalls":131,"k510s":133,"pmas":135},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":9,"submission_type_id":9,"definition":11,"implant_flag":12,"life_sustain_support_flag":12,"gmp_exempt_flag":13,"raw":14,"created_at":18,"updated_at":19,"recall_count":20,"latest_recall_date":12,"k510_count":20,"pma_count":20,"event_count":21},1067,"RGI","Hand Washing Sanitizer","N","","Unknown","An ultraviolet wavelength noncoherent light source used for sanitizing hands after washing.",null,true,{"openfda":15,"definition":11,"device_name":7,"review_code":9,"device_class":8,"implant_flag":9,"product_code":6,"review_panel":9,"gmp_exempt_flag":16,"third_party_flag":9,"medical_specialty":9,"regulation_number":9,"submission_type_id":9,"unclassified_reason":9,"life_sustain_support_flag":9,"medical_specialty_description":10,"summary_malfunction_reporting":17},{},"Y","Ineligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:48.758894+00:00",0,1,[],[24,32,40,48,56,64,73,81,88,96],{"medical_device_id":25,"generic_name":26,"class_classification":27,"jmdn_code":28,"name_similarity":29,"definition_similarity":29,"vector_similarity":30,"score":31},2346,"殺菌水製造装置","Ⅱ","70475000",0.1875,0.685792,0.032002,{"medical_device_id":33,"generic_name":34,"class_classification":27,"jmdn_code":35,"name_similarity":36,"definition_similarity":37,"vector_similarity":38,"score":39},2326,"除染・滅菌用洗浄器","14413000",0.131148,0.111498,0.670914,0.0277459,{"medical_device_id":41,"generic_name":42,"class_classification":27,"jmdn_code":43,"name_similarity":44,"definition_similarity":45,"vector_similarity":46,"score":47},2345,"紫外線浄水装置","35435000",0.0740741,0.15625,0.700408,0.0163934,{"medical_device_id":49,"generic_name":50,"class_classification":51,"jmdn_code":52,"name_similarity":53,"definition_similarity":54,"vector_similarity":55,"score":47},3802,"手・指用副木","Ⅰ","16210000",0.235294,0.146789,0.622193,{"medical_device_id":57,"generic_name":58,"class_classification":51,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},3561,"セル洗浄遠心機","35901000",0.216216,0.077748,0.590518,0.016129,{"medical_device_id":65,"generic_name":66,"class_classification":67,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},1057,"単回使用視力補正用色付コンタクトレンズ","Ⅲ","37583000",0.0298507,0.144105,0.682855,0.015873,{"medical_device_id":74,"generic_name":75,"class_classification":51,"jmdn_code":76,"name_similarity":77,"definition_similarity":78,"vector_similarity":79,"score":80},3420,"握力計","35021000",0.176471,0.172222,0.625871,0.015625,{"medical_device_id":82,"generic_name":83,"class_classification":51,"jmdn_code":84,"name_similarity":85,"definition_similarity":86,"vector_similarity":87,"score":80},3864,"器具除染用洗浄器","35424000",0.102041,0.132979,0.682672,{"medical_device_id":89,"generic_name":90,"class_classification":27,"jmdn_code":91,"name_similarity":92,"definition_similarity":93,"vector_similarity":94,"score":95},2497,"ウォーターパッド加温装置","36854010",0.179487,0.122807,0.564189,0.0153846,{"medical_device_id":97,"generic_name":98,"class_classification":27,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":95},2956,"家庭用紫外線治療器","71013000",0.0338983,0.19469,0.677121,[],{"510k":105,"classification":106,"enforcement":107,"event":108,"pma":109,"warning_letter":110},"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":112,"definition_ja":113,"commentary_ja":114,"model_name":115,"source_hash":116,"reviewed_by":12,"reviewed_at":12,"created_at":117,"updated_at":117},"手指消毒用紫外線照射器","手洗い後の手指消毒に使用される、非コヒーレント紫外線波長光源である。","本品は、米国では規制対象となる医療機器としての分類がなされておらず、デバイスクラスや21 CFRの該当条文も設定されていません。そのため、市販前届出（510(k)）や市販前承認（PMA）といった審査区分の適用も規定されておらず、FDAによる医療機器としての規制の枠組みの外に位置づけられています。","claude-sonnet-5","9fe60f0c363ccde45f91bd72e81000692697a594d0a710d88d703ef5869ff56b","2026-08-24T03:37:43.881155+00:00",{"product_code":6,"summary_ja":119,"stats":120,"stats_hash":129,"model_name":115,"created_at":130,"updated_at":130},"本製品コードについては、510(k)およびPMAの届出・承認実績は確認されていません。不具合報告は累計約1件で、区分は「その他」となっており、直近5年間の報告はありません。回収についても、これまでのところ報告は確認されていません。",{"pma":121,"k510":122,"as_of":123,"events":124,"recalls":126,"top_problems":128},{"latest":12,"originals":20,"supplements":20},{"total":20,"last5y":20,"latest":12,"applicants":20},"2026-08",{"death":20,"other":21,"total":21,"injury":20,"last5y":20,"malfunction":20,"latest_month":125},"2015-12",{"total":20,"last5y":20,"latest":12,"class_i":20,"class_ii":20,"class_iii":20,"top_root_causes":127},[],[],"9e5a8fb14a44cfb75956f99a9fa38a03c4eff86dd8cbba741a55a6c787c08c58","2026-08-24T05:22:13.607018+00:00",{"items":132,"total":20},[],{"items":134,"total":20},[],{"items":136,"total":20},[]]