Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EmbraceMini

K-Number: K252981 · 2025-12-22

ApplicantEmpatica S.r.l.
Decision Date2025-12-22
Product CodeLEL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EmbraceMini is the device name listed in this FDA 510(k) record. The listed applicant is Empatica S.r.l.. It received FDA 510(k) clearance on 2025-12-22 under 510(k) number K252981. The device is classified under product code LEL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EmbraceMini?

EmbraceMini is a medical device that received FDA 510(k) clearance on 2025-12-22. The listed applicant is Empatica S.r.l.. The 510(k) number is K252981.

When did EmbraceMini receive FDA 510(k) clearance?

EmbraceMini received FDA 510(k) clearance on 2025-12-22, under 510(k) number K252981.

Who is the listed applicant for EmbraceMini?

The FDA 510(k) record lists Empatica S.r.l. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EmbraceMini?

The FDA product code for EmbraceMini is LEL.

Other records listing Empatica S.r.l. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care PortalK250515EpiMonitorK242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalK232915EpiMonitorK230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalK221282Empatica Health Monitoring Platform

View all 9 devices →

Related Devices (Code: LEL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251574Sleep WatchAmbulatory Monitoring, Inc.K243513DCM (PW-DCM)Pneumowave, Ltd.K233987VERABAND™Arbor Medical Innovations, LLCK233618Oxevision Sleep DeviceOxehealth LimitedK231532ActiGraph LEAP activity monitor (ActiGraph LEAP)Actigraph, LLCK181077ActiGraph CentrePoint Insight WatchActigraph

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑