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SPEAC System Electrode Patch-SPC15-900431

FDA UDI

Class II (US FDA UDI)

by Brain Sentinel, Inc.

Identity

Trade Name
SPEAC System Electrode Patch-SPC15-900431 FDA UDI
Generic Name
Home seizure monitoring system FDA UDI
Device Name
The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System, is a physiological, surface electromyography (sEMG) monitor with or without alarms that records and stores data for review by a physician for characterization of seizure events. The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with an algorithm using the default threshold or by a modified threshold ordered by the physician. The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTC seizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that may be associated with such seizures are detected. The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced with the second sEMG Monitor on the opposite arm of the patient. The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting the sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base Station. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit, Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-secured within Microsoft Azure which is FedRAMP certified. FDA UDI
Model / Reference
SPC15 FDA UDI
Description
The SPEAC® System, formerly known as the Brain Sentinel® Monitoring and Alerting System, is a physiological, surface electromyography (sEMG) monitor with or without alarms that records and stores data for review by a physician for characterization of seizure events. The System records sEMG data at 1,000 Hz and distributes physiological data. Data can be analyzed with an algorithm using the default threshold or by a modified threshold ordered by the physician. The sEMG monitor is worn unilaterally on the belly of the patient’s biceps and it analyzes for sEMG GTC seizures and provides local, remote, audible, and visual seizure alarms when a GTC Seizure pattern that may be associated with such seizures are detected. The SPEAC System provides sEMG recordings and audio data to physicians (or other trained healthcare professionals) for post-hoc review so that they may quantify and qualify the types of seizure events that their patients experience. Every 24 hours, the sEMG monitor is removed from the patient and replaced with the second sEMG Monitor on the opposite arm of the patient. The sEMG Monitor that is removed after 24-hours is then attached to a Base Station. By connecting the sEMG Monitor to the Base Station, the monitor charges and the recorded data is downloaded to the Base Station. The recorded data is then automatically uploaded to Brain Sentinel’s cloud-based storage unit, Data Distribution System (DDS), where it awaits review by a physician. All patient data is cyber-secured within Microsoft Azure which is FedRAMP certified. FDA UDI

Identifiers

Catalog Number
SPC15-90043 FDA UDI
Primary DI / UDI-DI
B481SPC15900430 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-SPC15-900431 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 498cb466-afc8-4a5e-86f8-a39ccde0d38f 35 fields · synced Jun 8, 2026