FDA.reportPublic FDA data

SPEAC System

Primary DI
B481SPC150
Brand
SPEAC System
Company
BRAIN SENTINEL, INC.
Model
SPC15
Device description
The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct toseizure monitoring in adults in the home or healthcare facilities during periods of rest. Thedevice 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 toprovide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could beassociated with a GTC seizure. The System records and stores sEMG data for subsequentreview by a trained healthcare professional.
Published
2017-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
POSPhysiological Signal Based Seizure Monitoring System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POSPhysiological Signal Based Seizure Monitoring SystemNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN140033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN140033000CompanionLgch, Inc.2017-02-16POS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B481SPC150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Home seizure monitoring systemAn assembly of devices intended to detect and record a seizure by continuous measurement of one or more physical/physiological parameters (e.g., body motion, electrical activity of the heart or skeletal muscles) in a patient with epilepsy during daily activities and/or sleep in the home; some types may also be used in clinical settings. It typically consists of a mains electricity (AC-powered) central monitor that wirelessly receives, records, and displays the data, and one or more battery-powered body-worn sensor(s); it may have alarms and data may be transmitted to a cloud-based storage, server or mobile device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity45 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity45 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
969967764
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B481SPC15900541AccuSense Sensitive Electrode Patch-SPC15-90054 USSPC15SPC15-90054 2019-11-07
B481SPC15900551AccuSense Sensitive Electrode Patch SPC15-90055 EUSPC15SPC15-900552019-11-07
B481SPC15900580SPEAC System Assy, Mini Monitor, EUSPC15SPC15-900582019-09-05
B481SPC15900180SPEAC System Electrode Patch SPC15-90018SPC15SPC15-900182019-09-04
B481SPC15900430SPEAC System Electrode Patch-SPC15-900431SPC15SPC15-900432019-09-04
B481SPC15900440SPEAC System Electrode Patch SPC15-90044, EUSPC15SPC15-900442019-09-04
B481SPC15900450SPEAC System Electrode Patch-SPC15-90045, EUSPC15SPC15-900452019-09-04
B481SPC15900570SPEAC System Assy, Mini Monitor, USSPC15SPC15-900572019-09-04
B481SPC15900441SPEAC System Electrode Patch SPC15-90044, EUSPC15SPC15-900442019-08-26
B481SPC15900451SPEAC System Electrode Patch-SPC15-90045, EUSPC15SPC15-900452019-08-26
B481SPC15900181SPEAC System Electrode Patch SPC15-90018SPC15SPC15-900182019-08-13
B481SPC15900431SPEAC System Electrode Patch-SPC15-900431SPC15SPC15-9004312019-08-13
B481SPC15900571SPEAC System Assy, Mini Monitor, USSPC15SPC15-900572019-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013047702EpiWatchEpiwatch, Inc.POS2026-03-20
08719327236086NightWatch+ USLivassured B.V.POS2026-01-06
00853858006379EpiMonitorEMPATICA SRLPOS2024-08-14
00853858006386EpiMonitorEMPATICA SRLPOS2024-08-14
00853858006102Embrace2EMPATICA SRLPOS2020-02-11
00853858006119Embrace2EMPATICA SRLPOS2020-02-11
00853858006126Embrace2EMPATICA SRLPOS2020-02-11
00853858006133Embrace2EMPATICA SRLPOS2020-02-11
00853858006140Embrace2EMPATICA SRLPOS2020-02-11
B481SPC15900541AccuSense Sensitive Electrode Patch-SPC15-90054 USBRAIN SENTINEL, INC.POS2019-11-07
B481SPC15900551AccuSense Sensitive Electrode Patch SPC15-90055 EUBRAIN SENTINEL, INC.POS2019-11-07
B481SPC15900580SPEAC System Assy, Mini Monitor, EUBRAIN SENTINEL, INC.POS2019-09-05
B481SPC15900180SPEAC System Electrode Patch SPC15-90018BRAIN SENTINEL, INC.POS2019-09-04
B481SPC15900430SPEAC System Electrode Patch-SPC15-900431BRAIN SENTINEL, INC.POS2019-09-04
B481SPC15900440SPEAC System Electrode Patch SPC15-90044, EUBRAIN SENTINEL, INC.POS2019-09-04
B481SPC15900450SPEAC System Electrode Patch-SPC15-90045, EUBRAIN SENTINEL, INC.POS2019-09-04
B481SPC15900570SPEAC System Assy, Mini Monitor, USBRAIN SENTINEL, INC.POS2019-09-04
B481SPC15900441SPEAC System Electrode Patch SPC15-90044, EUBRAIN SENTINEL, INC.POS2019-08-26
B481SPC15900451SPEAC System Electrode Patch-SPC15-90045, EUBRAIN SENTINEL, INC.POS2019-08-26
B481SPC15900181SPEAC System Electrode Patch SPC15-90018BRAIN SENTINEL, INC.POS2019-08-13
B481SPC15900431SPEAC System Electrode Patch-SPC15-900431BRAIN SENTINEL, INC.POS2019-08-13
B481SPC15900571SPEAC System Assy, Mini Monitor, USBRAIN SENTINEL, INC.POS2019-08-13
08538580061026Embrace2EMPATICA SRLPOS2018-11-09
08538580061194Embrace2EMPATICA SRLPOS2018-11-09
08538580061262Embrace2EMPATICA SRLPOS2018-11-09
08538580061330Embrace2EMPATICA SRLPOS2018-11-09
08538580061408Embrace2EMPATICA SRLPOS2018-11-09