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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
Room703-711, No.2 North Taoyuan Road
ningbo,  CN 315600
Applicant Contact rodney zhang
Correspondent
WAT Medical Technology (Ningbo) Co., Ltd
Room703-711, No.2 North Taoyuan Road
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
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