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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 K172809
Device Name OTC Combo TENS/EMS System
Applicant
Well-Life Healthcare Limited
1F, No.16, Lane 454, Jungjeng Road
Yunghe Dist, New Taipei City,  TW 234
Applicant Contact Chin-Chih Hsieh
Correspondent
Well-Life Healthcare Limited
1F, No.16, Lane 454, Jungjeng Road
Yunghe Dist, New Taipei City,  TW 234
Correspondent Contact Chin-Chih Hsieh
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
NGX   NYN  
Date Received09/18/2017
Decision Date 10/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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