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.
2025-11-04
SIGNIFIER MEDICAL TECHNOLOGIES LIMITED
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3018192374 | 3018192374 | SIGNIFIER MEDICAL TECHNOLOGIES LIMITED | 1 | N | 2026-01-01 | Pall Mall, 1 Pollen Sq, 59 King Street Manchester GB M2 4PD |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 303108 | 2017451702 | K240328 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | QNO | 2024-05-16 |
| 303108 | 1371739498 | K223446 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | QNO | 2023-01-18 |
| 303108 | 1115795257 | DEN200018 | eXciteOSA with remote and eXciteOSA without remote | QNO | 2021-02-05 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QNO | 3 | 2024-05-16 |
GUDID#
eXciteOSA - eXciteOSA mouthpiece. eXciteOSA is intended for the reduction of primary snoring and obstructive sleep apnoea by strengthening tongue muscles via electrical muscle stimulation.
2024-08-14
eXciteOSA - eXciteOSA control unit.eXciteOSA is intended for the reduction of primary snoring and obstructive sleep apnoea by strengthening tongue muscles via electrical muscle stimulation.
2024-08-14