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510(k) K252981

EmbraceMini by Empatica S.R.L. — Product Code LEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2025
Date Received
September 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sleep Assessment
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

Other clearances by Empatica S.R.L.

  • K250515 — EpiMonitor (June 19, 2025)
  • K242737 — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (June 6, 2025)
  • K232915 — EpiMonitor (February 15, 2024)
  • K230457 — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (October 30, 2023)
  • K221282 — Empatica Health Monitoring Platform (November 20, 2022)
  • K181861 — Embrace (December 20, 2018)
  • K172935 — Embrace (January 26, 2018)

Other clearances for product code LEL

  • K251574 — Sleep Watch (July 31, 2025)
  • K243513 — DCM (PW-DCM) (April 16, 2025)
  • K233987 — VERABAND™ (June 17, 2024)
  • K233618 — Oxevision Sleep Device (April 3, 2024)
  • K231532 — ActiGraph LEAP activity monitor (ActiGraph LEAP) (June 23, 2023)
  • K181077 — ActiGraph CentrePoint Insight Watch (May 24, 2018)
  • K151784 — ActTrust (May 25, 2016)
  • K132764 — MOTION WATCH AND PRO-DIARY (January 21, 2014)
  • K111514 — SBV2, MULTICHARGER MODEL MC10V2 (December 16, 2011)
  • K040932 — EASYNET BODY POSITION MODULE (July 1, 2004)