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Disposable Adhesive Surface Electrodes, Disc Electrodes

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K073532

by Technomed Europe

Identifiers

510(k) Number
K073532 FDA 510(k)
FDA Product Code
GXY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1320 FDA 510(k)
Regulation Number
882.1320 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Disposable Adhesive Surface Electrodes, Disc Electrodes, are classified as Disposable Electrodes under the FDA’s nomenclature. These single-use, adhesive disc electrodes are designed for non-invasive electrical signal detection, typically used in electrodiagnostic procedures such as electromyography (EMG) and electroencephalography (EEG). Their adhesive backing ensures secure attachment to the skin, facilitating reliable and consistent signal transmission during monitoring or testing.

These electrodes are supplied sterile and intended for single-use only, adhering to standard clinical hygiene practices. They are compatible with MRI environments when used as directed, though their adhesive properties may require removal prior to MRI scanning. Available in standard disc sizes, they are packaged individually or in multi-packs for clinical convenience. Authorised under FDA 510(k) clearance, they comply with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR)

Frequently asked questions

Are these electrodes reusable or meant for single-use, and why does that matter for clinical settings?

These electrodes are designed for single-use only, which aligns with standard clinical hygiene practices to prevent cross-contamination. Their sterile packaging ensures safety for each patient encounter, reducing infection risks. Single-use also eliminates the need for cleaning or reprocessing, simplifying workflow and ensuring consistent performance without degradation from reuse.

What sizes are available for these disc electrodes, and how are they typically packaged for clinical use?

The electrodes come in standard disc sizes, though the exact dimensions are not specified in the data. They are packaged either individually or in multi-packs for convenience, allowing clinicians to choose based on their procedure needs—whether for single-patient use or bulk stocking in a clinical setting.

Can these electrodes be used in MRI environments, and if so, what precautions should be taken?

Yes, these electrodes are compatible with MRI environments when used as directed, meaning they won’t interfere with the magnetic field itself. However, their adhesive backing may require removal prior to MRI scanning to avoid potential issues with residual materials or interference during imaging. Always follow manufacturer guidelines for safe use.

How do I know these electrodes meet regulatory standards, and what committees were involved in their approval?

These electrodes are authorized under FDA 510(k) clearance (K073532), classified as substantially equivalent to a predicate device, and reviewed by the Neurology (NE) Advisory Committee. They also comply with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) in Europe, ensuring they meet stringent safety and performance requirements for electrodiagnostic use.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Technomed Europe

Sources (2)

  • FDA 510(k) K073532 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026