K202523 is an FDA 510(k) clearance for the TMJ Relax. This device is classified as a Mouthguard, Migraine/tension Headache.
Submitted by Moonwalker Innovations, Inc. (Medford, US). The FDA issued a Cleared decision on June 24, 2021, 296 days after receiving the submission on September 1, 2020.
This device falls under the Dental FDA review panel. 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..
| 510(k) Number | K202523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2020 |
| Decision Date | June 24, 2021 |
| Days to Decision | 296 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | OCO - Mouthguard, Migraine/tension Headache |
| Device Class | - |
| 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. |