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FDA 510(k)

TheraFace Mask

K-Number: K230293 · 2023-06-09

ApplicantTherabody, Inc.
Decision Date2023-06-09
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TheraFace Mask is the device name listed in this FDA 510(k) record. The listed applicant is Therabody, Inc.. It received FDA 510(k) clearance on 2023-06-09 under 510(k) number K230293. 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 Mask?

TheraFace Mask is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Therabody, Inc.. The 510(k) number is K230293.

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

TheraFace Mask received FDA 510(k) clearance on 2023-06-09, under 510(k) number K230293.

Who is the listed applicant for TheraFace Mask?

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

What is the FDA product code for TheraFace Mask?

The FDA product code for TheraFace Mask is OHS.

Other records listing Therabody, 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.

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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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