DEN200018 is an FDA 510(k) submission for the eXciteOSA with remote and eXciteOSA without remote. This device is classified as a Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea (Class II - Special Controls, product code QNO).
Submitted by Signifier Medical Technologies (London, GB). The FDA issued a Not Cleared (DENG) decision on February 5, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5575. A Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea Consists Of A Removable Intraoral Mouthpiece That Uses Electrodes To Deliver Neuromuscular Stimulation To The Tongue To Strengthen Tongue Musculature To Reduce Snoring And Obstructive Sleep Apnea..
| 510(k) Number | DEN200018 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 24, 2020 |
| Decision Date | February 05, 2021 |
| Days to Decision | 318 days |
| Submission Type | Direct |
| Review Panel | Dental (DE) |
| Summary | - |
| Product Code | QNO - Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5575 |
| Definition | A Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea Consists Of A Removable Intraoral Mouthpiece That Uses Electrodes To Deliver Neuromuscular Stimulation To The Tongue To Strengthen Tongue Musculature To Reduce Snoring And Obstructive Sleep Apnea. |