OCO

Mouthguard, Migraine/Tension Headache

Product code

OCO

Device name

Mouthguard, Migraine/Tension Headache

Device class

Class U

Medical specialty

Unknown

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).