FDA.reportPublic FDA data

Cathay

Primary DI
16959006303541
Brand
Cathay
Company
CATHAY MANUFACTURING CORP.
Model
CM5050FC
Device description
TENs Electrodes
Published
2021-11-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16959006303541PackageGS1100In Commercial Distribution
26959006303548PackageGS18In Commercial Distribution
06959006303544PrimaryGS10
36959006303545Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695900630354116959006303541
2695900630354826959006303548
06959006303544069590063035446959006303544
3695900630354536959006303545

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode adhesive padA noninvasive device typically in the form of a gel pad designed to adhere an electrode (not included) to the skin surface during transcutaneous electrical stimulation. It has appropriate electrical conducting properties and is intended for a limited number of uses (consumable). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+862157878328176541381@qq.com

Regulatory Flags#

DUNS number
421287342
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959006303315AcuZoneAcuZone-40-2x4pigtail electrodes2020-11-13
06959006303322AcuZoneAcuZone-44-2x2 pigtail electrodes2020-11-13
06959006303339AcuZoneAcuZone-40-2x2SNAP electrodes2020-11-13
06959006303308AngelAngel-40-2x2 pigtails electrodes2020-11-13
06959006300437CathayGP202S-AB2024-06-19
06959006300444CathayGP202D-AB2024-06-19
06959006300451CathayGP202S-PB2024-06-19
06959006300468CathayGP202D-PB2024-06-19
06959006300475CathayGP202S-IB2024-06-19
06959006300482CathayGP202D-IB2024-06-19
06959006300505CathayGP202D-TB2023-10-08
06959006300772CathayGP202S-PCB2023-10-08
06959006300789CathayGP202D-PCB2023-10-08
06959006300819CathayGP202S-TCB2023-10-08
06959006300826CathayGP202D-TCB2023-10-08
06959006302981CathayCP10012023-10-08
06959006304404CathayGP202S-TCB2023-10-08
06959006304411CathayGP202D-TCB2023-10-08
06959006300499CathayGP202S-TB2023-10-08
16959006300502CathayGP202D-TB2023-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08720791372248CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372262CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372286CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372309CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372323CadwellTechnomed Engineering B.V.GXY2024-05-02