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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 a medical device manufactured by Theragun, Inc.. It received FDA 510(k) clearance on 2021-09-29 under approval 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. It is manufactured by Theragun, Inc.. The 510(k) number is K212238.

When was TheraFace Microcurrent approved by the FDA?

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

What company makes TheraFace Microcurrent?

TheraFace Microcurrent is manufactured by Theragun, Inc..

What is the FDA product code for TheraFace Microcurrent?

The FDA product code for TheraFace Microcurrent is NFO.

Related Clinical Trials

Other Devices by Theragun, Inc.

Related Devices (Code: NFO)

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.