QNO — Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea Class II
FDA product code QNO covers "Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea", a Class II medical device regulated under 21 CFR 872.5575. Submissions are reviewed by the Dental panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QNO
- Device Class
- Class II
- Regulation Number
- 872.5575
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240328 | signifier medical technologies | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | May 16, 2024 |
| K223446 | signifier medical technologies | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | January 18, 2023 |
| DEN200018 | signifier medical technologies | eXciteOSA with remote and eXciteOSA without remote | February 5, 2021 |