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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 K111781
Device Name GYMFORM DUAL FLEX BELT MODEL WB-162
Applicant
Well Brain International , Ltd.
100 Granville Rd.
Tsim Sha Tsui E., Kowloon
Hong Kong, Sar China,  CN CH
Applicant Contact VICTOR K WAI
Correspondent
Well Brain International , Ltd.
100 Granville Rd.
Tsim Sha Tsui E., Kowloon
Hong Kong, Sar China,  CN CH
Correspondent Contact VICTOR K WAI
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
IRO  
Date Received06/24/2011
Decision Date 07/11/2012
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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