K223446 is an FDA 510(k) clearance for the eXciteOSA without remote control (3000). 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, Ltd. (London, GB). The FDA issued a Cleared decision on January 18, 2023, 64 days after receiving the submission on November 15, 2022.
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 | K223446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2022 |
| Decision Date | January 18, 2023 |
| Days to Decision | 64 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| 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. |