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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name massager, therapeutic, electric
510(k) Number K210451
Device Name OrthoGold 100
Tissue Regeneration Technologies, LLC
251 Heritage Walk
Woodstock,  GA  30188
Applicant Contact John Warlick
M Squared Associates, INC
127 West 30th St Floor 9
New York,  NY  10001
Correspondent Contact Cherita James
Regulation Number890.5660
Classification Product Code
Date Received02/16/2021
Decision Date 05/05/2021
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