OCO — Mouthguard, Migraine/Tension Headache Class U
FDA product code OCO covers "Mouthguard, Migraine/Tension Headache", a Class U medical device. Submissions are reviewed by the DE panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OCO
- Device Class
- Class U
- Submission Type
- 510(k)
- Review Panel
- DE
- Implant
- No
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.