FDA.reportPublic FDA data

Konmed

Primary DI
06970935830048
Brand
Konmed
Company
Shenzhen Konmed Technology Co., Ltd.
Model
KM-408
Device description
Electrodes with silver conductive are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, wrist sleeve, elbow Sleeve and knee sleeve. The conductivity is derived from the silver content of the Nylon yarn. The electrodes are available in free size. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The electrodes can be used dry or wet when in contact with the skin. The entire surface of each electrode is very conductive having a resistance of less than 2ohms per inch. This low resistance provides low current density with uniform current distribution.
Published
2018-01-25
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
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
06970935830048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970935830048069709358300486970935830048

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile 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, 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-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544436531
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970935830635Pelvic Muscle TrainerKM516B2026-07-08
06970935830734Pelvic Muscle TrainerKM5102026-07-08
06970935830529KONMED /PelvifineKM508B2025-09-30
06970935830710PelvifineKM5002025-02-18
06970935830536KONMED /PelvifineKM5302021-10-25
06970935830543KONMED /PelvifineKM5312021-10-25
06970935830482KONMEDKM-5022024-03-05
06970935830499KONMEDKM-5032024-03-05
06970935830642KONMEDKM-5042024-03-05
06970935830659KONMEDKM-5052024-03-05
06970935830666KONMEDKM-5062024-03-05
06970935830673KONMEDKM-5072024-03-05
06970935830680KONMEDKM-50132024-03-05
06970935830697KONMEDKM-50182024-03-05
06970935830567KONMED /PelvifineKM530B2022-08-24
06970935830574KONMED /PelvifineKM531B2022-08-24
06970935830581KONMED /PelvifineKM5362022-08-24
06970935830598KONMED /PelvifineKM5372022-08-24
06970935830079KonmedKM-8032018-01-25
06970935830086KonmedKM-8082018-01-25

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