FDA.reportPublic FDA data

Empatica E4

Primary DI
00853858006324
Brand
Empatica E4
Company
EMPATICA SRL
Model
E4
Catalog number
E4
Published
2021-09-30
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
GZODevice, Galvanic Skin Response Measurement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZODevice, Galvanic Skin Response MeasurementNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853858006324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853858006324008538580063248538580063240853858006324

GMDN Terms#

Term, Definition table
TermDefinition
Skin electrical conductance meterAn electronic instrument designed to determine a patient’s electrodermal activity (EDA) [also known as galvanic skin response (GSR), psychogalvanic reflex (PGR), skin conductance response (SCR)] by measuring the electrical conductance of the skin and the tissue path between electrodes placed on the surface of the body (e.g., hands, feet, head), whereby a small electrical current is typically applied. It is used to assess changes in psychophysiological indicators related to autonomic sympathetic activity and emotional states (e.g., fear, startle, pain); sudomotor dysfunction and subsequent reduced EDA have been associated with various conditions (e.g., neuropathy in diabetic patients).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
430141750
Device count
1
Premarket exempt
true
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
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
08538580061026Embrace2EmbraceEM2-MB-S2018-11-09
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
05999860882046QUEX EDQX WORLD LTDGZO2026-04-27
05999860882053QUEX SQX WORLD LTDGZO2026-04-27
05999860882060QUEX EDQX WORLD LTDGZO2026-04-27
05999860882077QUEX SQX WORLD LTDGZO2026-04-27
00853858006546Empatica Health Monitoring PlatformEMPATICA SRLGZO2026-02-16
00853858006751Empatica Health Monitoring PlatformEMPATICA SRLGZO2026-02-16
00853858006584EmpaticaEMPATICA SRLGZO2025-06-26
00850068747092Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747108Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747115Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747122Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747139Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747146Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747153Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747160Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747177Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
08690020003024SudoCheckMedeia, Inc.GZO2025-02-05
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-11-15
00840067103999CadwellCADWELL INDUSTRIES, INC.GZO2024-08-23
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-08-23
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-06-21
B322G0011ANS1 SoftwareLD TECHNOLOGY, LLCGZO2024-03-05
00840067102879Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-03-04
00840067102886Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-03-04
00840067102893Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-03-04
00840067102909Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-03-04