FDA.reportPublic FDA data

Embrace2

Primary DI
08538580061026
Brand
Embrace2
Company
EMPATICA SRL
Model
Embrace
Catalog number
EM2-MB-S
Published
2018-11-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08538580061026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08538580061026085385800610268538580061026

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
430141750
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853858006522EmbraceMiniEmbraceMini FKM bandEMBM-1G-FB-B2026-02-16
00853858006546Empatica Health Monitoring PlatformEmbracePlus2 Silicone Band - White EBP2-1G-SB-W2026-02-16
00853858006713EmbraceMiniEmbraceMini stretchable bandEMBM-1G-SB-B2026-02-16
00853858006751Empatica Health Monitoring PlatformEmbracePlus2 with Elastic StrapEBP2-1G-FB-B2026-02-16
00853858006584EmpaticaEmbracePlus2 Stretchable Band - BlackEBP2-1G-FB-B2025-06-26
00853858006324Empatica E4E4E42021-09-30
00853858006379EpiMonitorEpiMonitor App iOS2024-08-14
00853858006386EpiMonitorEpiMonitor App Android2024-08-14
00853858006232Empatica Health Monitoring PlatformEmbracePlusEMBP-CC-MS2022-11-24
00853858006249Empatica Health Monitoring PlatformCare App iOS2022-11-24
00853858006256Empatica Health Monitoring PlatformCare App Android Version2022-11-24
00853858006263Empatica Health Monitoring PlatformCare Portal2022-11-24
00853858006102Embrace2EmbraceEM2-MB-S2020-02-11
00853858006119Embrace2EmbraceEM2-BB-S2020-02-11
00853858006126Embrace2EmbraceEM2-SG-S2020-02-11
00853858006133Embrace2EmbraceEM2-FP-S2020-02-11
00853858006140Embrace2EmbraceEM2-SB-S2020-02-11
08538580061194Embrace2EmbraceEM2-BB-S2018-11-09
08538580061262Embrace2EmbraceEM2-SG-S2018-11-09
08538580061330Embrace2EmbraceEM2-FP-S2018-11-09

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
08538580061194Embrace2EMPATICA SRLPOS2018-11-09
08538580061262Embrace2EMPATICA SRLPOS2018-11-09
08538580061330Embrace2EMPATICA SRLPOS2018-11-09
08538580061408Embrace2EMPATICA SRLPOS2018-11-09
B481SPC150SPEAC SystemBRAIN SENTINEL, INC.POS2017-09-01