# K202523: TMJ Relax

- Pathway: 510(k) (Traditional)
- Applicant: Moonwalker Innovations, Inc.
- Decided: Jun 24, 2021 after 296 days
- Product code: OCO (Mouthguard, Migraine/Tension Headache)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010876 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010876: Nti Tension Suppression System, Nti-Tss, Inc. (2001) Summary page 4.

## Indications for use
A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, and; For the prevention of bruxism and TMJ syndrome through reduction of trigeminally innervated muscular activity

Source page: https://510kreport.com/device/K202523
Methodology: https://510kreport.com/methodology