FDA.reportPublic FDA data

SUDOSCAN®

Primary DI
B122APH20
Brand
SUDOSCAN®
Company
IMPETO MEDICAL
Model
APH2
Catalog number
APH2
Device description
Hand electrodes standard
Published
2016-09-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
B122APH20PrimaryHIBCC0

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature65 Degrees Fahrenheit95 Degrees Fahrenheit
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature41 Degrees Fahrenheit113 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(858) 450-2800sales_us@impeto-medical.com
+33(0)143201640info@impeto-medical.com

Regulatory Flags#

DUNS number
279502673
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770025753010SUDOSCANHand electrodeDSPHD2022-08-01
03770025753027SUDOSCANFoot electrodeAPF22022-08-01
03770025753034SUDOSCANHand electrodeAPH22022-08-01
03770025753065SUDOSCANSUDOTESTADSPHD2022-08-01
03770025753072SUDOSCANDock feetDSPFD2022-08-01
03770025753089SUDOSCANSet ElectrodeDSP2022-08-01
03770025753096SUDOSCANSUDOSCAN2SUDO22022-08-01
03770025753133SUDOSCANMaster Unit SangoS2MU2022-08-01
B122ADSPHD0SUDOSCAN®SUDOSCAN SADSPHD2019-05-13
B122APF20SUDOSCAN®APF2APF22016-09-09
B122DSP0SUDOSCAN®DSPDSP2016-09-09
B122S2MU0SUDOSCAN®SUDOSCAN2S2MU2016-09-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00850068747153Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747160Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
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08690020003024SudoCheckMedeia, Inc.GZO2025-02-05
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