OCO
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Mouthguard, Migraine/Tension Headache
- Device class
- Unclassified
- Medical specialty
- Unknown
- 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.
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| Record | Firm | Date |
|---|---|---|
| TMJ Relax (K202523) | Moonwalker Innovations, Inc. | 2021-06-24 |
| The Luco Hybrid OSA Appliance (K160477) | Luco Hybrid Osa Appliance, Inc. | 2016-07-29 |
| NTI TENSION SUPPRESSION SYSTEM (K010876) | Nti-Tss, Inc. | 2001-06-20 |
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Every clearance here is in the API, with alerts when new ones post.