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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 K161453
Device Name WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
Applicant
WELL-LIFE HEALTHCARE LIMITED
1F, NO.16, LANE 454
JUNGJENG ROAD
YUNGHE CITY, TAIPEI COUNTY,  TW 234
Applicant Contact CHIN-CHIH HSIEH
Correspondent
WELL-LIFE HEALTHCARE LIMITED
1F, NO.16, LANE 454
JUNGJENG ROAD
YUNGHE CITY, TAIPEI COUNTY,  TW 234
Correspondent Contact CHIN-CHIH HSIEH
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
NGX   NYN  
Date Received05/26/2016
Decision Date 12/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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