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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 K231425
Device Name Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
Applicant
Wuxi Jiajian Medical Instrument Co., Ltd.
#35 Baiqiao Rd., Ehu Town, Xishan District
Wuxi,  CN 214116
Applicant Contact Wu Zhifang
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 602, #19 Dongbao Rd., Songjiang Area,
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number882.5890
Classification Product Code
NUH  
Date Received05/17/2023
Decision Date 03/27/2024
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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