FDA.reportPublic FDA data

ETEKCITY TENS Unit Electrode Pads(50x50mm)

Primary DI
00817915020043
Brand
ETEKCITY TENS Unit Electrode Pads(50x50mm)
Company
Vesync (US) Corporation
Model
ETU-P12
Published
2019-09-20
Public version status
Update
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
K141076000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141076000GARMENT ELECTRODESShenzhen Dongdixin Technology Co., Ltd.2014-11-14GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817915020040PackageGS12In Commercial Distribution
20817915020047PackageGS140In Commercial Distribution
00817915020043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081791502004010817915020040
2081791502004720817915020047
00817915020043008179150200438179150200430817915020043

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.

Regulatory Flags#

DUNS number
079578783
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817915020272Etekcity Smart Fitness ScaleEFS-A791-KUS2026-05-11
00817915020050ETEKCITY TENS Unit Electrode Pads(50x100mm)ETU-P122019-09-20
00817915020067Etekcity Smart Fitness ScaleESF932019-10-10
00817915020074Etekcity Smart Fitness ScaleFIT 8S2019-12-20
00817915020098Etekcity Smart Fitness ScaleESF172020-06-01
00817915020104Etekcity Smart Fitness ScaleESF182020-06-01
00817915020111Etekcity Smart Fitness ScaleESF242020-06-01
00817915020128Etekcity Smart Fitness ScaleESF282020-06-01
00817915020135Etekcity Smart Fitness ScaleESF372020-06-01
00817915020166Etekcity Smart Fitness ScaleESF14, ESF382020-08-01
00817915020180Etekcity Smart Fitness ScaleESF-5512021-05-31
00817915020197EtekcityEFS-E661-WUS2024-08-24
00817915020203EtekcityEFS-E661-KUS2024-08-24
00817915020210EtekcityEFS-A591S-KUST2024-11-04
00817915020234EtekcityEFS-C671-WUST2025-01-14
00817915020258Etekcity Neck Massager Heated ProENM-C221-WUS2025-03-31
00817915020265Etekcity Smart Fitness ScaleEFS-C651-WUS2025-07-01
00817915023211Etekcity Smart Fitness ScaleESF932024-03-22
00817915028216Etekcity Smart Fitness ScaleEFS-A591S-WUST2021-08-24
00817915028223Etekcity Smart Fitness ScaleEFS-A591S-KUST2021-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08720791378257Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378264Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378271Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378288Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378295Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378301Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378318Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378325Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378332Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378349Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378356Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08