510(k) K160477
K160477 is an FDA 510(k) premarket notification submitted by Luco Hybrid Osa Appliance, Inc. for the device "The Luco Hybrid OSA Appliance". The FDA issued a decision of Substantially Equivalent on Jul 29, 2016. The device falls under product code OCO (Mouthguard, Migraine/Tension Headache), a Class U device. Luco Hybrid Osa Appliance, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 29, 2016
- Date Received
- Feb 19, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Migraine/Tension Headache
- Device Class
- Class U
- Review Panel
- DE
- Submission Type
- 510(k)
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.