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FDA 510(k)

TheraFace LED

K-Number: K212155 · 2021-12-21

ApplicantTheragun, Inc.
Decision Date2021-12-21
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TheraFace LED is a medical device manufactured by Theragun, Inc.. It received FDA 510(k) clearance on 2021-12-21 under approval number K212155. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TheraFace LED?

TheraFace LED is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Theragun, Inc.. The 510(k) number is K212155.

When was TheraFace LED approved by the FDA?

TheraFace LED received FDA 510(k) clearance on 2021-12-21, under approval number K212155.

What company makes TheraFace LED?

TheraFace LED is manufactured by Theragun, Inc..

What is the FDA product code for TheraFace LED?

The FDA product code for TheraFace LED is OHS.

Other Devices by Theragun, Inc.

K211745RecoveryAir PRO K212238TheraFace Microcurrent

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Official Source

View on FDA Database →

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

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