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Konmed

FDA UDI

Class II (US FDA UDI)

by Shenzhen Konmed Technology Co., Ltd.

Identity

Trade Name
Konmed FDA UDI
Generic Name
Transcutaneous electrical stimulation electrode, single-use FDA UDI
Device Name
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. FDA UDI
Model / Reference
KM-408 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
06970935830048 FDA UDI
FDA Product Code
GXY FDA UDI
GMDN Term
Transcutaneous electrical stimulation electrode, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1320 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Transcutaneous electrical stimulation electrode, single-use

Konmed by Shenzhen Konmed Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transcutaneous electrical stimulation electrode, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Konmed Technology Co., Ltd.

Sources (1)

  • FDA UDI 48818236-dc79-4621-9dde-477f42fe11b4 33 fields · synced May 30, 2026