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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 K220503
Device Name TENS device-EmeTerm 2, Model: YF-ZTY-E2
Applicant
WAT Medical Technology Inc.
Room703-711, No.2 North Taoyuan Road
Ningbo,  CN 315600
Applicant Contact Joe Xu
Correspondent
WAT Medical Technology Inc.
Room703-711, No.2 North Taoyuan Road
Ningbo,  CN 315600
Correspondent Contact Joe Xu
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received02/22/2022
Decision Date 04/23/2022
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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