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 Moonwalker Innovations, Inc..

3
Total
3
Cleared
182d
Avg days
2001
Since
Stable submission activity - 0 submissions in the last 2 years

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

About Product Code OCO - Regulatory Context

510(k) Submission Activity

3 total 510(k) submissions under product code OCO since 2001, with 3 receiving FDA clearance (average review time: 182 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

OCO devices are reviewed by the Dental panel. Browse all Dental devices →