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FDA 510(k)

TheraFace Microcurrent

K-Number: K212238 · 2021-09-29

Decision Date2021-09-29
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TheraFace Microcurrent is the device name listed in this FDA 510(k) record. The listed applicant is Theragun, Inc.. It received FDA 510(k) clearance on 2021-09-29 under 510(k) number K212238. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TheraFace Microcurrent?

TheraFace Microcurrent is a medical device that received FDA 510(k) clearance on 2021-09-29. The listed applicant is Theragun, Inc.. The 510(k) number is K212238.

When did TheraFace Microcurrent receive FDA 510(k) clearance?

TheraFace Microcurrent received FDA 510(k) clearance on 2021-09-29, under 510(k) number K212238.

Who is the listed applicant for TheraFace Microcurrent?

The FDA 510(k) record lists Theragun, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TheraFace Microcurrent?

The FDA product code for TheraFace Microcurrent is NFO.

Other records listing Theragun, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: NFO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.