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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 K130074
Device Name GYMFORM ABS-A-ROUND
Applicant
WELL BRAIN INTERNATIONAL, LTD.
RM.1212, 12 FL, HARBOUR CRYSTAL CENTRE, NO. 100 GRANVILLE RD
HONG KONG,  CN 999077
Applicant Contact VICTOR K WAI
Correspondent
WELL BRAIN INTERNATIONAL, LTD.
RM.1212, 12 FL, HARBOUR CRYSTAL CENTRE, NO. 100 GRANVILLE RD
HONG KONG,  CN 999077
Correspondent Contact VICTOR K WAI
Regulation Number890.5850
Classification Product Code
NGX  
Date Received01/14/2013
Decision Date 08/15/2013
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
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