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SPEAC System Electrode Patch-SPC15-90045, EU

FDA UDI

Class II (US FDA UDI)

by Brain Sentinel, Inc.

Identity

Trade Name
SPEAC System Electrode Patch-SPC15-90045, EU FDA UDI
Generic Name
Home seizure monitoring system FDA UDI
Device Name
The Brain Sentinel® Seizure Detection and Warning System is an ambulatory system designed to monitor and analyze electromyography (EMG) data to detect the onset of a generalized tonic-clonic (GTC) seizure whether primary or focal onset with secondary generalization and to provide a warning signal to alert caregivers that a seizure is occurring. The system records EMG data (24/7) and is available for analysis of other motor events. The Brain Sentinel Seizure Detection and Warning System is intended for monitoring adults with a history or significant risk of generalized tonic-clonic seizures in the home or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs, and for continuous monitoring, night time or any other time of day, of individuals due to their history or risk of generalized tonic-clonic seizures and will withstand activities of daily living including showers and sleep. The Brain Sentinel Seizure Detection and Warning System is available by prescription only. FDA UDI
Model / Reference
SPC15 FDA UDI
Description
The Brain Sentinel® Seizure Detection and Warning System is an ambulatory system designed to monitor and analyze electromyography (EMG) data to detect the onset of a generalized tonic-clonic (GTC) seizure whether primary or focal onset with secondary generalization and to provide a warning signal to alert caregivers that a seizure is occurring. The system records EMG data (24/7) and is available for analysis of other motor events. The Brain Sentinel Seizure Detection and Warning System is intended for monitoring adults with a history or significant risk of generalized tonic-clonic seizures in the home or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs, and for continuous monitoring, night time or any other time of day, of individuals due to their history or risk of generalized tonic-clonic seizures and will withstand activities of daily living including showers and sleep. The Brain Sentinel Seizure Detection and Warning System is available by prescription only. FDA UDI

Identifiers

Catalog Number
SPC15-90045 FDA UDI
Primary DI / UDI-DI
B481SPC15900450 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Home seizure monitoring system

SPEAC System Electrode Patch-SPC15-90045, EU 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 e9469282-6f5f-4ce4-bde7-bbce0463e5fc 35 fields · synced May 30, 2026