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Embrace

by Empatica S.r.L. Italy 510(k)

510(k) K181861

Product code POS

Overview

Embrace is a physiological signal based seizure monitoring system designed for individuals with epilepsy. It detects generalized tonic-clonic seizures and alerts caregivers, while also tracking sleep, rest, and physical activity.

The device is supplied as a single-use wearable biosensor and is regulated under FDA 510(k) clearance. It is intended for use in neurology and is classified as a Class 2 device.

Summary written by AI from registry data, 25 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 24 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181861 Date20 Dec 2018ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0159-2024 FDA Class II initiated 13 Jul 2023

    May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.

Specification

510(k) · synced 6 Oct 2026

510(k) Number
FDA Product Code
POS
Device Class
Class II
Regulation
21 CFR Part 882.1580
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Empatica S.r.L.

See all devices from Empatica S.r.L. →

Questions

  • What is the Embrace device used for?

    Embrace is a physiological signal based seizure monitoring system designed for individuals with epilepsy. It detects generalized tonic-clonic seizures and alerts caregivers, while also tracking sleep, rest, and physical activity.

  • How is the Embrace device supplied?

    The device is supplied as a single-use wearable biosensor.

  • What is the regulatory status of the Embrace device?

    The Embrace device is regulated under FDA 510(k) clearance and is classified as a Class 2 device.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K181861 24 fields · synced 6 Oct 2026