FDA.reportPublic FDA data

iReliev

Primary DI
00853635002037
Brand
iReliev
Company
EXCELHEALTH, INC.
Model
ET-1313
Catalog number
ET-1313
Device description
iReliev TENS Pain Relief System, 40 per Case
Published
2016-06-27
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
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091757000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091757000OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407Well-Life Healthcare Limited2010-02-05NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853635002034PackageGS140In Commercial Distribution
00853635002037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085363500203410853635002034
00853635002037008536350020378536350020370853635002037

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
406-672-6066info@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
00853635002464iRelievET-5252ET-52522018-01-12
00853635002747iRelievET-8080ET-80802018-07-20
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
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00817717023136SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00851913006296UltraStim Wire FoamAXELGAARD MANUFACTURING CO., LTD.GXY2026-10-21
00810093080854PainPodHi-Dow International IncorporatedNUH2026-10-19
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
06971712720415CriterionHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-10-15
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-10-13
06973602731105Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
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06973602731129Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
00850080988671AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988688AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988695AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
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