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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
Theragun, Inc.
6100 Wilshire Blvd, Suite 200
Los Angeles,  CA  90048
Applicant Contact Jaime Sanchez
Schiff & Company, Inc.
583 Mountain Avenue
North Caldwell,  NJ  07006
Correspondent Contact Thomas Padula
Regulation Number890.5650
Classification Product Code
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