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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K211745
Device Name RecoveryAir PRO
Applicant
Theragun, Inc.
6100 Wilshire Blvd., Suite 200
Los Angeles,  CA  90048
Applicant Contact Jaime Sanchez
Correspondent
Schiff & Company, Inc.
583 Mountain Ave.
North Caldwell,  NJ  07006
Correspondent Contact Thomas Padula
Regulation Number890.5650
Classification Product Code
IRP  
Date Received06/07/2021
Decision Date 10/04/2021
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
Predetermined Change
Control Plan Authorized		 No
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