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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 K213120
Device Name OW100S (model OW100S-US)
Applicant
Tissue Regeneration Technologies, LLC Dba AS Softwave Trt
251 Heritage Walk
Woodstock,  GA  30188
Applicant Contact John Warlick
Correspondent
Msquared Associates, Inc.
127 W. 30th St.,
9th Floor
New York,  NY  10001
Correspondent Contact Cherita James
Regulation Number890.5660
Classification Product Code
ISA  
Date Received09/27/2021
Decision Date 10/12/2022
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
Predetermined Change
Control Plan Authorized		 No
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