FDA.reportPublic FDA data

SweatC

Primary DI
B322A0011
Brand
SweatC
Company
LD TECHNOLOGY, LLC
Model
A001
Device description
SweatC device is a medical device for the measurement of galvanic skin response related to the function of the sweat glands.
Published
2019-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GZODevice, Galvanic Skin Response Measurement

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152216000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152216000SudoCLd Technology, LLC2015-09-24GZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B322A0011PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
305-379-9900albert.ldteck@gmail.com

Regulatory Flags#

DUNS number
079443785
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B322H0011LD-EKGH0012024-03-05
B322B0011TM-Oxi SystemB0012019-01-16
B322E0011BP-BT Lifeprobes Kiosk E0012024-03-05
B322F0011ES-BC F0012024-03-05
B322G0011ANS1 SoftwareG0012024-03-05
B322C0011TBL-ABIC0012019-01-16
B322D0011LD-OxyD0012019-01-16

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