# K172935: Embrace

- Pathway: 510(k) (Traditional)
- Applicant: Empatica S.r.l.
- Decided: Jan 26, 2018 after 122 days
- Product code: POS (Physiological Signal Based Seizure Monitoring System)
- Device class: 2
- Regulation: 21 CFR 882.1580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN140033 (2017). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN140033: Companion, Lgch, Inc. (2017) Summary page 4.

## Most influential descendants
- K181861: Embrace (2018), 5 descendants of its own
- K232915: EpiMonitor (2024), 1 descendant of its own
- K251506: Nelli (Version 7.11) (2025), 0 descendants of its own
- K243199: NightWatch+ US (2025), 0 descendants of its own
- K250515: EpiMonitor (2025), 0 descendants of its own

## Indications for use
The Embrace is a prescription only device that is indicated for use as an adjunct to seizure monitoring of adults in home or healthcare facilities during periods of rest. The device is worn on the wrist, and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with generalized tonic clonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, Embrace sends a command to a paired wireless device that is programmed to initiate an alert to a designated caregiver. The System records and stores data from Accelerometers, EDA, and Temperature for subsequent review by a trained healthcare professional.

Source page: https://510kreport.com/device/K172935
Methodology: https://510kreport.com/methodology