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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
510(k) Number K123354
Device Name REVITIVE IX
Applicant
Actegy , Ltd.
555 13th St. NW
Washington,  DC  20004
Applicant Contact JOHN J SMITH
Correspondent
Actegy , Ltd.
555 13th St. NW
Washington,  DC  20004
Correspondent Contact JOHN J SMITH
Regulation Number890.5850
Classification Product Code
IPF  
Date Received10/31/2012
Decision Date 06/28/2013
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
Predetermined Change
Control Plan Authorized		 No
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