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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 K152480
Device Name Revitive Medic; Revitive MV; Revitive LV
Applicant
Actegy, Ltd.
Reflex, Cain Road
Bracknell,  GB RG12 1HL
Applicant Contact Angela Glover
Correspondent
DOHMEN LIFE SCIENCE SERVICES, LLC
11925 W I-70 FRONTAGE RD. NORTH, SUITE 900
WHEAT RIDGE,  CO  80033
Correspondent Contact Deanna Hughes
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
NUH  
Date Received08/31/2015
Decision Date 03/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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