OCOUnclassified
Mouthguard, Migraine/Tension Headache
Unknown
OCO is the FDA product code for Mouthguard, Migraine/Tension Headache. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OCO
- Device name
- Mouthguard, Migraine/Tension Headache
- FDA 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.
- Device class
- Unclassified
- Review panel
- Unknown
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 0
Clearances, product code OCO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2016 | 1 |
| 2021 | 1 |
Applicants with the most clearances
Product code OCO| Applicant | Clearances |
|---|---|
| Luco Hybrid Osa Appliance, Inc. | 1 |
| Moonwalker Innovations, Inc. | 1 |
| Nti-Tss, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.