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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 K141299
Device Name OTC COMBO TENS/EMS SYSTEM
Applicant
WELL-LIFE HEALTHCARE LIMITED
1FL, NO.16, LANE 454
JUNGJENG RD.
YUNGHE CITY, TAIPEI COUNTY,  TW 234
Applicant Contact CHIN-CHIH HSIEH
Correspondent
WELL-LIFE HEALTHCARE LIMITED
1FL, NO.16, LANE 454
JUNGJENG RD.
YUNGHE CITY, TAIPEI COUNTY,  TW 234
Correspondent Contact CHIN-CHIH HSIEH
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
NGX   NYN  
Date Received05/19/2014
Decision Date 11/14/2014
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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