FDA.reportPublic FDA data

iReliev

Primary DI
00853635002464
Brand
iReliev
Company
EXCELHEALTH, INC.
Model
ET-5252
Catalog number
ET-5252
Device description
iReliev PlayMakar Reusable Electrode Pad
Published
2018-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
10853635002461PackageGS1500In Commercial Distribution
00853635002464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085363500246110853635002461
00853635002464008536350024648536350024640853635002464

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode, single-useAn electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
855-723-2582wecare@ireliev.com

Regulatory Flags#

DUNS number
079213529
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853635002426iRelievET-5050ET-50502018-01-12
00853635002440iRelievET-5555ET-55552018-01-12
00853635002457iRelievET-5454ET-54542018-01-12
00853635002747iRelievET-8080ET-80802018-07-20
00853635002037iRelievET-1313ET-13132016-06-27
00853635002051iRelievCM5050-4CM5050-42016-06-27
00853635002112iRelievCM5050CM50502016-06-27
00853635002259iRelievET-7070ET-70702016-06-27
00853635002266iRelievET-1515ET-15152016-06-27
00853635002273iRelievET-7171ET-71712016-06-27
00853635002280iRelievET-7272ET-72722016-06-27
00853635002433iRelievET-5050ET-50502018-01-12
10853635002447iRelievET-5555ET-55552018-01-12
20853635002741iRelievET-8080ET-80802018-07-20
20853635002451iRelievET-5454ET-54542018-01-12
10853635002461iRelievET-5252ET-52522018-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817717023105SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00817717023112SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00817717023129SENSADERM BLUEVision Quest Industries IncorporatedGXY2026-10-23
00817717023136SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00851913006296UltraStim Wire FoamAXELGAARD MANUFACTURING CO., LTD.GXY2026-10-21
00382830063821NatusXLTEKGXY2026-10-15
00382830063838NatusXLTEKGXY2026-10-15
00382830063845NatusXLTEKGXY2026-10-15
00382830063852NatusXLTEKGXY2026-10-15
00382830063869NatusXLTEKGXY2026-10-15
00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
06973602731105Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731112Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731129Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
00850080988718AUVONUAN HEALTHCARE LIMITEDGXY2026-10-08
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