TipTraQ
TipTraQ is a fingertip wearable device intended to aid sleep apnea evaluation or diagnosis in adults suspected of sleep apnea. The filing describes home-based and clinical-use environments.…
TipTraQ is a fingertip wearable device intended to aid sleep apnea evaluation or diagnosis in adults suspected of sleep apnea.
The filing describes home-based and clinical-use environments. It identifies the device as prescription-only.
Listed Item
TipTraQ Kit Version: FIN-10008 & FIN-10009
Recorded Signals and Outputs
The system includes a fingertip wearable, mobile app, cloud-based analysis and an information display. It collects PPG and accelerometer data.
The algorithm determines total sleep time, total REM time, oxygen desaturation index and apnea-hypopnea index from recorded waveforms.
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 | Pranaq PTE. Ltd., Singapore |
|---|---|
| FDA product code | MNR |
| Device type | Ventilatory Effort Recorder |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2375 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K243268 |
| Record published | 2026-05-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2026-05-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TTQ001 | In distribution | |
| TTQ001 | In distribution | |
| TTQ001 | Withdrawn | |
| TTQ001 | Withdrawn |
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 |
|---|---|
| K243268 | 2025-02-03 |
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.