[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PKA":3},{"classification":4,"mappedDevices":31,"similarCandidates":32,"relatedClassifications":116,"syncDates":117,"translation":124,"marketSummary":131,"recalls":145,"k510s":147,"pmas":160},{"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":26,"updated_at":27,"recall_count":28,"latest_recall_date":29,"k510_count":30,"pma_count":28,"event_count":28},3590,"PKA","External Upper Esophageal Sphincter (Ues) Compression Device","2","874.5900","EN","Ear, Nose, Throat","1","The external UES compression device is intended to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":23,"device_class":8,"implant_flag":24,"product_code":6,"review_panel":10,"gmp_exempt_flag":24,"third_party_flag":24,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":23,"life_sustain_support_flag":24,"medical_specialty_description":11,"summary_malfunction_reporting":25},{"k_number":17,"fei_number":20,"registration_number":22},[18,19],"K173934","DEN130046",[21],"3039167637",[21],"","N","Eligible","2026-08-18T05:52:51.341121+00:00","2026-08-24T02:00:48.366308+00:00",0,null,2,[],[33,42,51,59,67,75,84,92,100,108],{"medical_device_id":34,"generic_name":35,"class_classification":36,"jmdn_code":37,"name_similarity":38,"definition_similarity":39,"vector_similarity":40,"score":41},539,"経食道体外型心臓ペースメーカ","Ⅲ","36046000",0.246753,0.198413,0.729382,0.0327869,{"medical_device_id":43,"generic_name":44,"class_classification":45,"jmdn_code":46,"name_similarity":47,"definition_similarity":48,"vector_similarity":49,"score":50},2365,"経食道体外型心臓ペースメーカ用電極","Ⅱ","41474000",0.22093,0.226923,0.697309,0.031746,{"medical_device_id":52,"generic_name":53,"class_classification":45,"jmdn_code":54,"name_similarity":55,"definition_similarity":56,"vector_similarity":57,"score":58},1407,"食道内圧力モニタ","35248000",0.205882,0.223176,0.691618,0.0303309,{"medical_device_id":60,"generic_name":61,"class_classification":45,"jmdn_code":62,"name_similarity":63,"definition_similarity":64,"vector_similarity":65,"score":66},3179,"中耳加圧装置","47542002",0.228916,0.21223,0.668962,0.0302135,{"medical_device_id":68,"generic_name":69,"class_classification":45,"jmdn_code":70,"name_similarity":71,"definition_similarity":72,"vector_similarity":73,"score":74},1977,"単回使用気道食道栓塞子","42420000",0.1625,0.249211,0.678651,0.0267483,{"medical_device_id":76,"generic_name":77,"class_classification":78,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":83},3786,"食道結さつ器","Ⅰ","34137000",0.177419,0.199248,0.667134,0.0265471,{"medical_device_id":85,"generic_name":86,"class_classification":78,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},4362,"食道拡張器","35009000",0.196721,0.184116,0.655582,0.0258492,{"medical_device_id":93,"generic_name":94,"class_classification":45,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},1952,"短期的使用食道・気管用二腔チューブ","70250002",0.170455,0.209091,0.661286,0.0249226,{"medical_device_id":101,"generic_name":102,"class_classification":36,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},681,"消化管用逆流防止補綴材","35695000",0.107143,0.198895,0.70161,0.016129,{"medical_device_id":109,"generic_name":110,"class_classification":78,"jmdn_code":111,"name_similarity":112,"definition_similarity":113,"vector_similarity":114,"score":115},3678,"食道挿管検出器","36290000",0.214286,0.23913,0.636011,0.015625,[],{"510k":118,"classification":119,"enforcement":120,"event":121,"pma":122,"warning_letter":123},"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":125,"definition_ja":126,"commentary_ja":127,"model_name":128,"source_hash":129,"reviewed_by":29,"reviewed_at":29,"created_at":130,"updated_at":130},"体外式上部食道括約筋圧迫装置","外部式UES圧迫装置は、胃内容物が上部食道括約筋を通過して逆流するのを軽減することにより、喉頭咽頭逆流症（LPR）の症状を軽減することを目的とする。","この機器は、喉頭咽頭逆流症の症状緩和を目的として体外から上部食道括約筋を圧迫する装置です。米国ではクラスIIに分類されており、市販前届出（510(k)）による審査を経て、既存の同等品との実質的同等性が確認されれば市販が認められます。","claude-sonnet-5","fbe1b2613ce6d9c6d34e33d170401b891cc5ac424374a3753297fc0347905486","2026-08-24T02:30:13.381035+00:00",{"product_code":6,"summary_ja":132,"stats":133,"stats_hash":143,"model_name":128,"created_at":144,"updated_at":144},"510(k)の累計件数は2件、参入企業数は1社となっており、直近5年の届出実績は確認されていません。不具合報告は累計0件で、回収についても記録は確認されていません。",{"pma":134,"k510":135,"as_of":138,"events":139,"recalls":140,"top_problems":142},{"latest":29,"originals":28,"supplements":28},{"total":30,"last5y":28,"latest":136,"applicants":137},"2018-04-13",1,"2026-08",{"death":28,"other":28,"total":28,"injury":28,"last5y":28,"malfunction":28,"latest_month":29},{"total":28,"last5y":28,"latest":29,"class_i":28,"class_ii":28,"class_iii":28,"top_root_causes":141},[],[],"cbf944c21ab55e51a1d5c5d31f92a29bc62a9c9baf91bfcbf84b20117395796d","2026-08-24T05:13:39.867404+00:00",{"items":146,"total":28},[],{"items":148,"total":30},[149,155],{"k_number":18,"device_name":150,"applicant":151,"decision_date":136,"clearance_type":152,"decision_code":153,"statement_or_summary":154},"Reza Band, Reflux Band","Somna Therapeutics, LLC","Traditional","SESE","Summary",{"k_number":19,"device_name":156,"applicant":151,"decision_date":157,"clearance_type":158,"decision_code":159,"statement_or_summary":29},"REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE","2015-03-06","Direct","DENG",{"items":161,"total":28},[]]