FDA.reportPublic FDA data

Jiajian

Primary DI
00810011252301
Brand
Jiajian
Company
Wuxi Jiajian Medical Instrument Co.,Ltd.
Model
50*50mm
Device description
Flexible and easy to fit electrode can be applied to every contour of the human body. You can use the electrodes many times because of its reliable long lasting gel. 2 Electrodes in sealed foil pouch.
Published
2019-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090198000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090198000JIAJIAN SELF-ADHESIVE ELECTRODEWuxi Jiajian Medical Instrument Co., Ltd.2009-06-23GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810011252318PackageGS1800In Commercial Distribution
00810011252301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810011252318008100112523188100112523180810011252318
00810011252301008100112523018100112523010810011252301

GMDN Terms#

Term, Definition table
TermDefinition
Electrical probe/electrode conductive padA small, non-sterile device designed to facilitate electrical conduction between an electrical stimulation probe or electrode and the skin. It is typically contoured to fit on a particular type of probe/electrode and is made of an absorbent material (e.g., felt) that may be soaked in a conduction fluid. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529966489
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06932307410395JIAJIANCMNS6-1 PLUS2026-03-04
06932307410401JIAJIANCMNS6-32026-03-04
06932307410418JIAJIANTENS WMPS2-12026-03-04
06932307410432JIAJIANTENStem eco basic2026-03-04
06932307410449JIAJIANWQ-10D12026-03-04
06932307410456JIAJIANWQ-6F2026-03-04
06932307410425JIAJIANTENS WMPS6-12026-03-03
06972011718424JIAJIANCMNS6-12026-03-03
06972011718431JIAJIANCMNS6-22026-03-03
00810011251601JiajianTENS2019-02-19
04260505370046alegriaCare50*100mm2017-08-25
04260505370053alegriaCare50*100mm2017-08-28
04260505370084alegriaCare50*50mm2017-08-25
04260505370121alegriaCare50*502017-08-30
04260505370138alegriaCareround 32mm2017-08-30
00185098000854Infrared Heating devicePM-7502016-10-21
04260505370015alegriaCare50*50mm2017-08-25
04260505370022alegriaCare50*502017-08-30
04260505370039alegriaCare50*50mm2017-08-25
04260505370060alegriaCareRound 25mm2017-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720791379032Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379049Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379063Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379087Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
00816312028072Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-06-01
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372163CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372187CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372200CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372224CadwellTechnomed Engineering B.V.GXY2024-05-02