FDA.reportPublic FDA data

TensCare

Primary DI
05033435000722
Brand
TensCare
Company
TENSCARE LIMITED
Model
iGlove Large
Catalog number
K-GL-L
Device description
The iGlove Garment Electrode, is a pack of 2 reusable garment electrodes designed for wearing on your hands, with an intended use for the desired success of any stimulation (TENS or EMS). it is intended for a single user.
Published
2023-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171721000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171721000Electrodes with silver conductiveShenzhen Konmed Technology Co., Ltd.2018-01-05GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05033435000722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05033435000722050334350007225033435000722

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
569403736
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05033435134403TensCareKegel Fit 2K-KEGEL22024-11-18
05033435138777TensCareCool Relief Electrodes 50X50E-CR50502024-11-06
05033435138784TensCareCool Relief Electrodes 50X100E-CR501002024-11-06
05033435139118TensCareHypoallergenic ElectrodesE-TRBG2024-11-06
05033435139132TensCareCarbon Mesh Electrode pads 50X50 mmE-TR50502024-11-06
05033435139156TensCareCarbon Mesh Electrode pads 50X100 mmE-TR501002024-11-06
05033435139705TensCareBack ElectrodeE-TRALBA2024-11-06
05033435139712TensCareKnee ElectrodeK-TRALKN2024-11-06
05033435139729TensCareNeck ElectrodeE-TRALNE2024-11-06
05033435136933TensCareForm Duo2024-07-25
05033435138920TensCareOva3K-OVA32024-07-24
05033435134090TensCareOva+K-OVAP-USA2024-01-16
05033435136209TensCareUnifitK-UNIFIT2023-11-03
05033435135646TensCareUnicareK-UNICARE2023-10-24
05033435133796TensCareShockwaveK-SHOCKWAVE2023-06-08
05033435120413TensCareKneeStimK-KNEE2023-09-01
05033435000739TensCareiSock LargeK-SK-L2023-08-31
05033435070039TensCareiTouch SureK-ITS2023-08-31
05033435120239TensCareSports TENS 2K-ST22023-08-31
05033435131419TensCarePerfect EMSK-PEMS2023-08-31

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