# OCO · Mouthguard, Migraine/Tension Headache

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/DE-misc/OCO

## Overview

- **Product Code:** OCO
- **Device Name:** Mouthguard, Migraine/Tension Headache
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Identification

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.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K202523](https://fda.innolitics.com/submissions/DE/DE-misc/OCO/K202523.md) | TMJ Relax | Moonwalker Innovations, Inc. | Jun 24, 2021 | SESE |
| [K160477](https://fda.innolitics.com/submissions/DE/DE-misc/OCO/K160477.md) | The Luco Hybrid OSA Appliance | Luco Hybrid Osa Appliance, Inc. | Jul 29, 2016 | SESE |
| [K010876](https://fda.innolitics.com/submissions/DE/DE-misc/OCO/K010876.md) | NTI TENSION SUPPRESSION SYSTEM | Nti-Tss, Inc. | Jun 20, 2001 | SESE |

## Top Applicants

- Luco Hybrid Osa Appliance, Inc. — 1 clearance
- Moonwalker Innovations, Inc. — 1 clearance
- Nti-Tss, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/DE/DE-misc/OCO](https://fda.innolitics.com/submissions/DE/DE-misc/OCO)

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