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 a medical device manufactured by Therabody, Inc.. It received FDA 510(k) clearance on 2023-06-09 under approval 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. It is manufactured by Therabody, Inc.. The 510(k) number is K230293.
When was TheraFace Mask approved by the FDA?
TheraFace Mask received FDA 510(k) clearance on 2023-06-09, under approval number K230293.
What company makes TheraFace Mask?
TheraFace Mask is manufactured by Therabody, Inc..
What is the FDA product code for TheraFace Mask?
The FDA product code for TheraFace Mask is OHS.
Other Devices by Therabody, Inc.
Related Devices (Code: OHS)
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.