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510(k) K181861

Embrace by Empatica S.R.L. — Product Code POS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2018
Date Received
July 12, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Physiological Signal Based Seizure Monitoring System
Device Class
Class II
Regulation Number
882.1580
Review Panel
NE
Submission Type

The Physiological signal based seizure monitoring system is a prescription device that uses physiological signal to identify abnormal physiological activity that may be associated with a seizure. The System does not predict seizure onsets, and is not intended as a standalone seizure monitoring device.

Other clearances by Empatica S.R.L.

  • K252981 — EmbraceMini (December 22, 2025)
  • 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)
  • K172935 — Embrace (January 26, 2018)

Other clearances for product code POS

  • K251506 — Nelli (Version 7.11) (November 21, 2025)
  • K243199 — NightWatch+ US (July 12, 2025)
  • K250515 — EpiMonitor (June 19, 2025)
  • K243515 — EpiWatch Monitoring System (March 7, 2025)
  • K232915 — EpiMonitor (February 15, 2024)
  • K200276 — SPEAC System (February 6, 2021)
  • K182180 — SPEAC System (May 11, 2019)
  • K172935 — Embrace (January 26, 2018)
  • DEN140033 — Companion (February 16, 2017)