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SPEAC System

FDA UDI

Class II (US FDA UDI)

by Brain Sentinel, Inc.

Identity

Trade Name
SPEAC System FDA UDI
Generic Name
Home seizure monitoring system FDA UDI
Device Name
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. FDA UDI
Model / Reference
SPC15 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
B481SPC150 FDA UDI
510(k) Number
DEN140033 FDA UDI
FDA Product Code
POS FDA UDI
GMDN Term
Home seizure monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1580 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Home seizure monitoring system

SPEAC System by Brain Sentinel, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Home seizure monitoring system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Brain Sentinel, Inc.

Sources (1)

  • FDA UDI 0474573a-b881-4f23-a4e6-885aacf49253 35 fields · synced May 31, 2026