eXciteOSA
eXciteOSA remote control. eXciteOSA is intended for the reduction of primary snoring and obstructive sleep apnoea by strengthening tongue muscles via electrical muscle stimulation.
1manufacturer
3catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Milli-Henry Electronics Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
Record
| Listed by | Signifier Medical Technologies LLC, United States |
|---|---|
| FDA product code | QNO |
| Device type | Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5575 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2024-08-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 801600001 | In distribution | |
| 802300000 | In distribution | |
| 810000000 | In distribution |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240328 | 2024-05-16 |
| K223446 | 2023-01-18 |
| DEN200018 | 2021-02-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.