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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, #16, Ln. 454
Jungjeng Rd.
Yunghe City, Taipei County,  TW 234
Applicant Contact CHIN-CHIH HSIEH
Correspondent
Well-Life Healthcare Limited
1fl, #16, Ln. 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
Predetermined Change
Control Plan Authorized		 No
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