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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K252688
Device Name Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
Applicant
Bozhou Rongjian Medical Appliance Co., Ltd.
Jianghuai Supply Base, Zhongkai Group, Mengcheng County
Bozhou,  CN 233500
Applicant Contact Zhifang Wu
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 805, # 19 Dongbao Rd., Songjiang Area, Shanghai
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number882.5890
Classification Product Code
NUH  
Date Received08/26/2025
Decision Date 11/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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