FDA 510(k) · Empatica
K252981: EmbraceMini (Empatica S.r.l.)
Empatica S.r.l. received FDA 510(k) K252981 for EmbraceMini, with a decision date of Dec 22, 2025 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K252981 |
|---|---|
| Pathway | 510(k) |
| Applicant | Empatica S.r.l. |
| Device name | EmbraceMini |
| Product code | LEL: Device, Sleep Assessment |
| Regulation (21 CFR) | 882.5050 |
| Device class | Class 2 |
| Date received | Sep 17, 2025 |
| Decision date | Dec 22, 2025 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
EmbraceMini is a wearable device intended to be used by trained healthcare professionals or researchers to remotely monitor limb or body movements in ambulatory individuals in home-healthcare environments and professional healthcare environments. The device supports continuous data collection for monitoring the following physiological parameters: ● Physical movement associated with applications in physiological monitoring ● Activity associated with movement during sleep EmbraceMini can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K230457 Empatica Health Monitoring Platform; Em… (Empatica)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code LEL is "Device, Sleep Assessment", class 2, 21 CFR 882.5050.
Our labels for filtering: claim Sleep, sensor Wrist PPG. These are heuristics, not FDA fields.