Onera STS
Onera STS is a wearable system that records physiological signals during a prescribed adult sleep study. Four sensors are applied to the forehead, upper chest, abdomen and lower leg. The…
Onera STS is a wearable system that records physiological signals during a prescribed adult sleep study. Four sensors are applied to the forehead, upper chest, abdomen and lower leg. The system can be used at home or in a professional healthcare setting.
Recorded signals include brain, eye, muscle and cardiac electrical activity, respiratory effort and flow, oxygen saturation, activity, position and sound pressure. Respiratory measurements include bioimpedance-based effort and flow as well as cannula-based flow. Clinicians use the recorded information when evaluating sleep disorders.
Study Workflow
A physician or trained technician directs use, while a layperson can apply the sensors. A dedicated trained operator prepares the study and retrieves the data in a professional environment. The system records information for clinical interpretation; it does not independently diagnose, provide life-support monitoring or issue alarms.
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) | K210593 |
| Record published | 2023-03-15 |
| Record revised | 2026-05-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment temperature 10 to 40 °C |
| Sizes | Length 28 to 245 mm; width 46 to 116 mm; height 7 to 86 mm; weight 20 to 293 g |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01.00 | Weight 293 g | In distribution |
| 01.00 | Weight 20 g | In distribution |
| 01.00 | Length 66 mm | In distribution |
| 01.00 | Length 227.5 mm | In distribution |
| 01.00 | Length 66 mm | In distribution |
| 01.00 | In distribution | |
| 01.00 | Length 114 mm | In distribution |
| 01.00 | Length 160 mm | In distribution |
| 01.00 | Length 245 mm | In distribution |
| 01.00 | Length 227.5 mm | In distribution |
| 01.00 | Weight 20 g | In distribution |
| 01.00 | Length 204.5 mm | In distribution |
| 01.00 | Length 245 mm | In distribution |
| 01.00 | Weight 259 g | In distribution |
| 01.00 | Weight 34 g | In distribution |
| 01.00 | Weight 54 g | In distribution |
| 01.00 | Weight 20 g | In distribution |
| 01.00 | Length 66 mm | In distribution |
| 01.00 | Length 188 mm | In distribution |
| 01.00 | Length 204.5 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 |
| 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 |
| Alice PDx | 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.