OCO · Mouthguard, Migraine/Tension Headache
· Class U
Overview
| Product Code | OCO |
|---|---|
| Device Name | Mouthguard, Migraine/Tension Headache |
| Device Class | Class U |
| Review Panel |
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 | TMJ Relax | Moonwalker Innovations, Inc. | Jun 24, 2021 | SESE |
| K160477 | The Luco Hybrid OSA Appliance | Luco Hybrid Osa Appliance, Inc. | Jul 29, 2016 | SESE |
| K010876 | 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
