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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 K210825
Device Name Revitive Medic Coach (Model Number 5575AQ)
Applicant
Actegy, Ltd.
Reflex, Cain Road
Bracknell,  GB RG12 1HL
Applicant Contact Lawrence Brookfield
Correspondent
The Allis Law Firm, PLLC
2532 North Fourth Street, #620
Flagstaff,  AZ  86004
Correspondent Contact Carmelina Allis
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Codes
GZJ   IPF   NUH   NYN  
Date Received03/19/2021
Decision Date 12/17/2021
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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