| K-number | K253388 |
| Device name | Sleepiz One+ (Model 2.5) |
| Applicant | Sleepiz AG |
| Product code | DRT |
| Device class | Class II |
| Decision date | Jan 28, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.2300 |
Sleepiz One+ (Model 2.5) is a contactless medical device using radar technology to measure heart rate and respiration rate in adult patients at rest or during sleep, and to detect patient presence and body movements. The hardware unit transmits data via Wi-Fi to cloud-based software for analysis. It is intended for use by healthcare professionals in clinical settings or by patients/caregivers in home environments, but is not indicated for active patient monitoring or use on pregnant women.
The subject device is identical to the predicate device (K251364 Sleepiz One+) in design, materials, and principle of operation. Both use the same Doppler radar technology for signal acquisition, transmit data via Internet to backend servers, employ identical Application Programming Interface (API) links, and operate using the same plug-in power source.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov