OCO

FDA Product Code OCO: Mouthguard, Migraine/tension Headache

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.

Leading manufacturers include Nti-Tss, Inc., Luco Hybrid Osa Appliance, Inc. and Moonwalker Innovations, Inc..

3
Total
3
Cleared
182d
Avg days
2001
Since

FDA 510(k) Cleared Mouthguard, Migraine/tension Headache Devices (Product Code OCO)

3 devices
1–3 of 3
Cleared Jun 24, 2021
TMJ Relax
K202523
Moonwalker Innovations, Inc.
Dental · 296d
Cleared Jul 29, 2016
The Luco Hybrid OSA Appliance
K160477
Luco Hybrid Osa Appliance, Inc.
Dental · 161d
Cleared Jun 20, 2001
NTI TENSION SUPPRESSION SYSTEM
K010876
Nti-Tss, Inc.
Dental · 89d

About Product Code OCO - Regulatory Context