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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 a medical device manufactured by Empatica S.r.l.. It received FDA 510(k) clearance on 2025-12-22 under approval 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. It is manufactured by Empatica S.r.l.. The 510(k) number is K252981.

When was EmbraceMini approved by the FDA?

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

What company makes EmbraceMini?

EmbraceMini is manufactured by Empatica S.r.l..

What is the FDA product code for EmbraceMini?

The FDA product code for EmbraceMini is LEL.

Other Devices by Empatica S.r.l.

K181861Embrace K172935Embrace K221282Empatica Health Monitoring Platform K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal K232915EpiMonitor K250515EpiMonitor

View all 8 devices →

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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.

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