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Elefix Electrode Cream

FDA 510(k)

Class II (US FDA 510(k))

510(k) K860210

by Nihon Kohden America, Inc.

Identifiers

510(k) Number
K860210 FDA 510(k)
FDA Product Code
GYB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1275 FDA 510(k)
Regulation Number
882.1275 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Elefix Electrode Cream is an electroconductive media designed to reduce skin-electrode impedance during electrophysiological monitoring. It facilitates optimal signal transmission between electrodes and the patient’s skin, ensuring accurate readings in neurological assessments such as electroencephalography (EEG) or electromyography (EMG).

Supplied as a single-use, non-sterile cream in a tube, this device is intended for use in clinical settings where electrophysiological testing is performed. It is classified under FDA product code GYB and falls under Class II regulatory controls. The device was cleared via a 510(k) submission (K860210) in 1986 and remains authorized for distribution by Nihon Kohden America, Inc.

Frequently asked questions

What is the Elefix Electrode Cream used for?

The Elefix Electrode Cream is designed to reduce skin-electrode impedance during electrophysiological monitoring. This improves signal transmission between electrodes and the patient’s skin, ensuring accurate readings in neurological assessments like electroencephalography (EEG) or electromyography (EMG). By minimizing interference, it helps clinicians obtain reliable diagnostic data.

Is the Elefix Electrode Cream sterile and single-use?

The Elefix Electrode Cream is supplied as a single-use, non-sterile product in a tube. It is intended for clinical use in electrophysiological testing environments, where sterility is not required for this specific application. Always follow facility protocols for proper handling and disposal.

How is the Elefix Electrode Cream supplied, and what sizes are available?

The Elefix Electrode Cream is supplied in a tube format, designed for single-use applications. While the exact tube sizes are not specified in the provided data, it is commonly available in standard clinical sizes suitable for EEG and EMG procedures. For precise sizing details, refer to the manufacturer’s packaging or technical documentation.

What regulatory pathway does the Elefix Electrode Cream follow?

The Elefix Electrode Cream was cleared via a traditional 510(k) submission (K860210) by the FDA in 1986 and remains authorized for distribution. It falls under FDA product code GYB and is classified as a Class II medical device, regulated under the substantial equivalence determination for electroconductive media used in neurological assessments.

How should the Elefix Electrode Cream be stored?

While specific storage instructions are not detailed in the provided data, electroconductive creams like the Elefix Electrode Cream are generally stored in a cool, dry place away from direct sunlight. Ensure the tube is tightly sealed to maintain product integrity. Always check the manufacturer’s labeling or instructions for any additional storage recommendations.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ELEFIX ELECTRODE CREAM (K860210) — FDA 510 (k) | Innolitics, K860210 - ELEFIX ELECTRODE CREAM | FDA 510 (k), Elefix Electrode Cream 510 (k) FDA Premarket Notification K860210 NIHON ..., ELEFIX V Conductive EEG Paste - 6 oz tube - Bio-Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nihon Kohden America, Inc.

Sources (1)

  • FDA 510(k) K860210 24 fields · synced Oct 1, 2026