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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 K172478
Device Name TENS device-EmeTerm, CinvStop
Applicant
Wat Medical Technology (Ningbo) Co., Ltd.
Rm. 703-711, #2 N. Taoyuan Rd.
Ningbo,  CN 315600
Applicant Contact Joe Xu
Correspondent
Wat Medical Technology (Ningbo) Co., Ltd.
Rm. 703-711, #2 N. Taoyuan Rd.
Ningbo,  CN 315600
Correspondent Contact Rodney Zhang
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received08/16/2017
Decision Date 04/19/2018
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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