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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 K143207
Device Name Revitive IX (OTC)
Applicant
Actegy , Ltd.
8 Queen Sq., Ascot Business Park
Lyndhurst Rd.
Ascot,  GB Sl5 9FE
Applicant Contact Angela Glover
Correspondent
Hogan Lovells US LLP
Columbia Sq.
555 13th St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
NUH  
Date Received11/07/2014
Decision Date 03/23/2015
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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