Onera STS 2
The Onera Sleep Test System 2 records physiological signals during an adult sleep study prescribed by a healthcare professional. It can be used at home or in healthcare facilities under the…
The Onera Sleep Test System 2 records physiological signals during an adult sleep study prescribed by a healthcare professional. It can be used at home or in healthcare facilities under the direction of a physician or trained technician.
Five wearable sensors are applied to intact skin on the forehead, chest, abdomen and both lower legs. They record signals including EEG, eye and muscle activity, ECG, respiration, airflow, oxygen saturation, movement and position.
Data Transfer
Sensors send encrypted recordings by Bluetooth to a patient smartphone application, which transfers data for processing. The resulting EDF file is available for professional review. Sensors are single use for one study, and the system is not a life supporting physiological monitor.
Who Else Makes It
Concentrated in Fujian (1), Jiangsu (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
Record
| Listed by | Onera B.V., Netherlands |
|---|---|
| FDA product code | MNR |
| Device type | Ventilatory Effort Recorder |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2375 |
| Establishment | Manufacturer |
| 510(k) | K243220 |
| Record published | 2026-05-15 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment temperature 10 to 40 °C |
| Sizes | Length 188 mm; width 109 mm; height 7 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01.00 | Length 188 mm | In distribution |
| 01.00 | Length 188 mm | In distribution |
| 01.00 | In distribution | |
| 01.00 | In distribution | |
| 01.00 | In distribution | |
| 01.00 | Length 188 mm | In distribution |
| 01.00 | Length 188 mm | In distribution |
| 01.00 | Length 188 mm | In distribution |
| 01.00 | Length 188 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sleepsense | S. L. P. Scientific Laboratory Products Ltd | 182 |
| TriplePlay | Dymedix Diagnostics Inc | 71 |
| Embla | S. L. P. Scientific Laboratory Products Ltd | 36 |
| Grass | S. L. P. Scientific Laboratory Products Ltd | 31 |
| Xltek | Embla Systems | 30 |
| Alice NightOne | Respironics Inc. | 22 |
| Onera STS | Onera B.V. | 21 |
| Natus | S. L. P. Scientific Laboratory Products Ltd | 21 |
| Night Shift | Advanced Brain Monitoring, Inc. | 19 |
| Neurovirtual | Neurovirtual USA, Inc. | 18 |
| SOMNOtouch Resp accessory | Somnomedics AG | 18 |
| zRIP | Respironics Inc. | 17 |
Showing 12 of 259. All products under Ventilatory Effort Recorder
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243220 | 2025-07-03 |
| K223573 | 2023-08-18 |
| K210593 | 2022-04-06 |
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.