Compumedics Somfit D
Somfit D is a single-use prescription sleep recorder for home assessment of adults aged 21 years and older with suspected sleep-related breathing disorders. It provides clinicians with…
Somfit D is a single-use prescription sleep recorder for home assessment of adults aged 21 years and older with suspected sleep-related breathing disorders. It provides clinicians with physiological signals, sleep stages and snoring information as a diagnostic aid.
The battery-powered unit attaches to the forehead using an adhesive electrode patch. It records frontal electrical signals, pulse-related optical signals, oxygen saturation, movement and sound. A phone application receives data through Bluetooth and transfers it for storage and processing.
Listed Item
Somfit D (Single)
Clinical Interpretation
The software reports indices including a peripheral-arterial-tonometry-derived apnoea-hypopnoea index and sleep-stage information. Results are not the sole or primary basis for diagnosis or treatment, and the device is not intended for life-support monitoring.
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 | Compumedics Limited, Australia |
|---|---|
| FDA product code | MNR |
| Device type | Ventilatory Effort Recorder |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2375 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K252383 |
| Record published | 2026-03-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Packaging | Pack of 10, pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Somfit D | 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 |
|---|---|
| K252383 | 2025-08-28 |
| K231546 | 2023-11-30 |
| K072201 | 2008-04-14 |
| K021176 | 2003-01-21 |
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.