510(k) K202523
K202523 is an FDA 510(k) premarket notification submitted by Moonwalker Innovations, Inc. for the device "TMJ Relax". The FDA issued a decision of Substantially Equivalent on Jun 24, 2021. The device falls under product code OCO (Mouthguard, Migraine/Tension Headache), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 24, 2021
- Date Received
- Sep 1, 2020
- 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.