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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, for pain relief
510(k) Number K222879
Device Name Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
Applicant
Wuxi Jiajian Medical Instrument Co., Ltd
No.35 Baiqiao Rd., Ehu Town, Xishan District,
WuXi,  CN 214116
Applicant Contact Wu Zhifang
Correspondent
Wuxi Jiajian Medical Instrument Co., Ltd
No.35 Baiqiao Rd., Ehu Town, Xishan District,
WuXi,  CN 214116
Correspondent Contact Wu Zhifang
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/22/2022
Decision Date 01/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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