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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K262664
Device Name Rongjian Self-adhesive Electrode
Applicant
Bozhou Rongjian Medical Appliance Co., Ltd.
Jianghuai Supply Base,Zhongkai Group,Mengcheng County
Bozhou,  CN 233500
Applicant Contact Wu zhi fang
Correspondent
Bozhou Rongjian Medical Appliance Co., Ltd.
Jianghuai Supply Base,Zhongkai Group,Mengcheng County
Bozhou,  CN 233500
Correspondent Contact Wu zhi fang
Regulation Number882.1320
Classification Product Code
GXY  
Date Received07/30/2026
Decision Date 10/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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