TMJ Relax

Mouthguard, Migraine/tension Headache

Moonwalker Innovations Inc

The following data is part of a premarket notification filed by Moonwalker Innovations Inc with the FDA for Tmj Relax.

Pre-market Notification Details

• Device ID: K202523
• 510k Number: K202523
• Device Name: TMJ Relax
• Classification: Mouthguard, Migraine/tension Headache
• Applicant: Moonwalker Innovations Inc 20 Roosevelt Rd Medford, MA 02155
• Contact: Charles Sutera
• Correspondent: Charles Sutera; Moonwalker Innovations Inc 20 Roosevelt Rd Medford, MA 02155
• Product Code: OCO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-09-01
• Decision Date: 2021-06-24