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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 the device name listed in this FDA 510(k) record. The listed applicant is Moonwalker Innovations, Inc.. It received FDA 510(k) clearance on 2021-06-24 under 510(k) 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. The listed applicant is Moonwalker Innovations, Inc.. The 510(k) number is K202523.

When did TMJ Relax receive FDA 510(k) clearance?

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

Who is the listed applicant for TMJ Relax?

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

What is the FDA product code for TMJ Relax?

The FDA product code for TMJ Relax is OCO.

Related Devices (Code: OCO)

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.

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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