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FDA 510(k)

TMJ Relax

K-Number: K202523 · 2021-06-24

ApplicantMoonwalker Innovations, Inc.
Decision Date2021-06-24
Product CodeOCO
DecisionSubstantially Equivalent

Device Summary

TMJ Relax is a medical device manufactured by Moonwalker Innovations, Inc.. It received FDA 510(k) clearance on 2021-06-24 under approval number K202523. The device is classified under product code OCO. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TMJ Relax?

TMJ Relax is a medical device that received FDA 510(k) clearance on 2021-06-24. It is manufactured by Moonwalker Innovations, Inc.. The 510(k) number is K202523.

When was TMJ Relax approved by the FDA?

TMJ Relax received FDA 510(k) clearance on 2021-06-24, under approval number K202523.

What company makes TMJ Relax?

TMJ Relax is manufactured by Moonwalker Innovations, Inc..

What is the FDA product code for TMJ Relax?

The FDA product code for TMJ Relax is OCO.

Related Devices (Code: OCO)

K160477The Luco Hybrid OSA ApplianceLuco Hybrid Osa Appliance, Inc.

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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