TheraFace Microcurrent

FDA 510(k) K212238 · Theragun, Inc.

Substantially Equivalent

510(k) numberK212238

Submission

Device name
TheraFace Microcurrent
Applicant
Theragun, Inc.
Los Angeles, CA, US
Received
July 19, 2021
Decision date
September 29, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

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Questions and answers

When was TheraFace Microcurrent cleared by the FDA?

TheraFace Microcurrent (K212238) received a 510(k) decision of Substantially Equivalent on September 29, 2021, 72 days after the submission was received.

What is the product code of K212238?

The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.