FDA 510(k)

TMJ Relax

Número K: K202523 · 2021-06-24

Data da decisão2021-06-24

Código do produtoOCO

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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