FDA.reportPublic FDA data

"2x4"" Rectangle Fabric Electrode"

Primary DI
00860019001654
Brand
"2x4"" Rectangle Fabric Electrode"
Company
ELITE MEDICAL SUPPLY OF NY
Model
SF50100WP
Device description
"2x4"" rectangle white non-woven fabric cutaneous hydrogel electrode, package contains 4 individual electrodes."
Published
2018-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00860019001654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860019001654008600190016548600190016540860019001654

GMDN Terms#

Term, Definition table
TermDefinition
Interferential electrical stimulation system electrodeA component of an interferential electrical stimulation system designed to conduct electrical currents from the system's pulse generator to specific areas of the body typically to treat pain. In interferential treatment it is typical to use two electrical conductors (electrodes) that are attached to the patient's skin at opposite corners of a square along which currents are delivered (e.g., 4000 and 41000 Hz) that interfere at its centre. This results in a beat frequency at the difference between the frequencies and this is used to treat muscle disorders or, at higher frequencies, to relieve pain. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Inch
Width2Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
716-712-0881jmcgrady@elitemedicalsupplyofny.com
716-712-0881jnikiel@elitemedicalsupplyofny.com

Regulatory Flags#

DUNS number
608469891
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860019001609Tri-Wave Combination StimulatorEMS1002018-03-16
00860019001630Multi-Mode StimulatorPMD20002018-03-19
00860019001616"2"" square fabric electrode"SF5050WP2018-03-19
00860019001623Tri-Wave Combination StimulatorEMS1002018-03-16
00860019001647Multi-Mode StimulatorPMD20002018-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
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08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
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08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
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08720791378431Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08