TheraFace Microcurrent

Stimulator, Transcutaneous Electrical, Aesthetic Purposes

Theragun, Inc.

The following data is part of a premarket notification filed by Theragun, Inc. with the FDA for Theraface Microcurrent.

Pre-market Notification Details

Device IDK212238
510k NumberK212238
Device Name:TheraFace Microcurrent
ClassificationStimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant Theragun, Inc. 6100 Wilshire Blvd, Suite 200 Los Angeles,  CA  90048
ContactJaime Sanchez
CorrespondentThomas Padula
Schiff & Company, Inc. 583 Mountain Avenue North Caldwell,  NJ  07006
Product CodeNFO  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-19
Decision Date2021-09-29

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