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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 the device name listed in this FDA 510(k) record. The listed applicant is Theragun, Inc.. It received FDA 510(k) clearance on 2021-12-21 under 510(k) 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. The listed applicant is Theragun, Inc.. The 510(k) number is K212155.

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

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

Who is the listed applicant for TheraFace LED?

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 LED?

The FDA product code for TheraFace LED is OHS.

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.

K211745RecoveryAir PROK212238TheraFace Microcurrent

Related Devices (Code: OHS)

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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.

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