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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
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