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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 K133723
Device Name OTC PATCH
Applicant
Well-Life Healthcare Limited
1fl, #16, Lane 454
Jungjeng Rd.
Yunghe City, Taipei County,  TW 234
Applicant Contact CHIN-CHIN HSIEH
Correspondent
Well-Life Healthcare Limited
1fl, #16, Lane 454
Jungjeng Rd.
Yunghe City, Taipei County,  TW 234
Correspondent Contact CHIN-CHIN HSIEH
Regulation Number882.5890
Classification Product Code
NUH  
Date Received12/06/2013
Decision Date 01/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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