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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K212238
Device Name TheraFace Microcurrent
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 Number882.5890
Classification Product Code
NFO  
Date Received07/19/2021
Decision Date 09/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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