FDA.reportPublic FDA data

AVCOO

Primary DI
10850073128173
Brand
AVCOO
Company
ADP HEALTH LIMITED
Model
EB2M20
Catalog number
EB2M20C21
Device description
The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface between the patient’s skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.
Published
2025-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160138000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160138000Adhesive ElectrodesGmdasz Manufacturing Co., Ltd.2016-08-11GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850073128173PackageGS1120In Commercial Distribution
00850073128176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085007312817310850073128173
00850073128176008500731281768500731281760850073128176

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 678-829-7251support@avcoo.com

Regulatory Flags#

DUNS number
101747972
Device count
1
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
00850073128275AVCOO Adhesive ElectrodesEB2M20EB2M20V0112026-01-28
10850073128272AVCOO Adhesive ElectrodesEB2M20EB2M20V0112026-01-28
00850073128183AVCOOTC1241TC12410Q12025-09-19
00850073128190AVCOOTC2241TC22410Q12025-09-19
10850073128180AVCOOTC1241TC12410Q12025-09-19
10850073128197AVCOOTC2241TC22410Q12025-09-19
00850073128169AVCOOTA2224CTA2224CC112025-09-18
00850073128176AVCOOEB2M20EB2M20C212025-09-18
10850073128166AVCOOTA2224CTA2224CC112025-09-18
00850073128138AVCOOTS2321AS9020EC142025-08-25
00850073128121AVCOOTS2301AS9020EBC132025-08-25
10850073128135AVCOOTS2321AS9020EC142025-08-25
00850073128107AVCOOTA2224CTA2224CC112025-07-02
10850073128104AVCOOTA2224CTA2224CC112025-07-02
00850073128091AVCOOJT9020E108500731280982025-05-26
00850073128084AVCOOJT9020EAS9020EBC132025-05-26
10850073128098AVCOOJT9020E108500731280982025-05-26
00850073128046AVCOOTU1130TU1130CR22025-04-03
10850073128043AVCOOTU1130TU1130CR22025-04-03
00850073128008AVCOOTA2224CTA2224CC122025-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
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
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08