# DEN140033: Companion

- Pathway: De Novo (Direct)
- Applicant: Lgch, Inc.
- Decided: Feb 16, 2017 after 829 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
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K172935: Embrace (2018), 6 descendants of its own
- K181861: Embrace (2018), 5 descendants of its own
- K232915: EpiMonitor (2024), 1 descendant of its own
- K182180: SPEAC System (2019), 1 descendant of its own
- K251506: Nelli (Version 7.11) (2025), 0 descendants of its own

## Indications for use
The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures and to provide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.

Source page: https://510kreport.com/device/DEN140033
Methodology: https://510kreport.com/methodology