FDA.reportPublic FDA data

EpiWatch

Primary DI
00860013047702
Brand
EpiWatch
Company
Epiwatch, Inc.
Model
1
Device description
Seizure detection algorithm app for tonic clonic seizure detection, alerting and monitoring
Published
2026-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K243515000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243515000EpiWatch Monitoring SystemEpiwatch, Inc.2025-03-07POS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013047702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013047702008600130477028600130477020860013047702

GMDN Terms#

Term, Definition table
TermDefinition
Clinical management support softwareAn application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, and/or links to guidelines) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. Also known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118597858
Device count
1

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
B481SPC150SPEAC SystemBRAIN SENTINEL, INC.POS2017-09-01