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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 K190924
Device Name Revitive Medic Plus, Revitive Advanced 2
Applicant
Actegy, Ltd.
Reflex, Cain Road
Bracknell,  GB RG12 1HL
Applicant Contact Lawrence Brookfield
Correspondent
The Allis Law Firm, PLLC
2437 Bay Area Blvd. #30
Houston,  TX  77058
Correspondent Contact Carmelina Allis
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Codes
IPF   NUH   NYN  
Date Received04/09/2019
Decision Date 07/05/2019
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
Predetermined Change
Control Plan Authorized		 No
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