Therapeutic devices · 21 CFR 872 Subpart F
Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea
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.
- Companies listing it
- 44 makers
- Brands and models
- 9
- 510(k) clearances
- 32 in five years
- FDA name
- Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
510(k) clearances per year, 1976–2026
Companies that list QNO
4 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Signifier Medical Technologies Limited | United Kingdom | Maker | eXciteOSA · eXciteOSA control unit only pack (warranty replacement) (17000) · eXciteOSA full system - with remote control (18010) · eXciteOSA mouthpiece replacement (16000) · +3 | 3 | 2024 |
| Freudenberg Medical Europe GmbH | Germany | Maker | eXciteOSA | — | — |
| Milli-Henry Electronics Co., Ltd. | China | Maker | eXciteOSA, Neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea | — | — |
| Seacomp Displays | Mexico | Maker | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 16 May 2024 | K240328 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | Signifier Medical Technologies Limited |
| 18 Jan 2023 | K223446 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | Signifier Medical Technologies Limited |
| 5 Feb 2021 | DEN200018 | eXciteOSA with remote and eXciteOSA without remote | Signifier Medical Technologies Limited |
Official records: FDA product classification for QNO · 21 CFR 872.5575.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026