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
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
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