SOMNOtouch Resp
Somnotouch Resp is a portable physiological recorder that helps assess adult sleep and sleep-related breathing disorders. A physician prescribes use in the office, sleep laboratory or…
Somnotouch Resp is a portable physiological recorder that helps assess adult sleep and sleep-related breathing disorders. A physician prescribes use in the office, sleep laboratory or patient’s home.
The thorax-worn recorder measures chest effort, body position and movement. A nasal cannula records airflow and snoring, a finger sensor measures oxygen saturation and pulse, and a separate abdominal sensor records respiratory effort.
Data Review
Signals are stored in internal flash memory and transferred to a computer through a USB docking station. Dominolight software displays, analyzes and stores the recordings. The system does not automatically diagnose disorders and is not intended for life-support situations.
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 | Somnomedics AG, Germany |
|---|---|
| FDA product code | MNR |
| Device type | Ventilatory Effort Recorder |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2375 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K140861 |
| Record published | 2016-09-18 |
| Record revised | 2025-02-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TOR050U | 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 |
|---|---|
| K140861 | 2015-01-30 |
| K081485 | 2008-09-18 |
| K071556 | 2007-07-18 |
| K060708 | 2007-01-24 |
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.