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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning
510(k) Number K142055
Device Name GYMFORM ABS & CORE
Applicant
Well Brain International , Ltd.
Rm. 03, 14/F, Fook Yip Blg., 53-57
Kwai Fung Crescent
Kwai Chung, N.T.,  HK
Applicant Contact VICTOR K WAI
Correspondent
Well Brain International , Ltd.
Rm. 03, 14/F, Fook Yip Bldg., 53-57
Kwai Fung Crescent
Chung, N.T.,  HK
Correspondent Contact VICTOR K WAI
Regulation Number890.5850
Classification Product Code
NGX  
Date Received07/29/2014
Decision Date 05/11/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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