Electrode Using Promeon RG-60 Series Gel

• • Terminated Z-0500-2013 FDA Class II ·initiated 9 Feb 2012

  Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.

510(k) Number

K915333 ↗

FDA Product Code

GXY

Device Class

Class II

Regulation

21 CFR Part 882.1320

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Labeltape Meditect, Inc. →

• What is the Promeon RG-60 Gel Electrode used for?

  The Promeon RG-60 Gel Electrode is designed for non-invasive electrical stimulation and recording of neural activity. It is specifically used in neurology for procedures like electromyography (EMG), electroencephalography (EEG), and nerve conduction studies. The gel enhances conductivity, ensuring stable signal transmission during diagnostic or monitoring applications.

• Is the electrode single-use or reusable?

  The electrode is supplied as a single-use item, intended for sterile application in clinical settings. This design ensures patient safety and hygiene by preventing cross-contamination between uses.

• What are the key features of the Promeon RG-60 Gel?

  The Promeon RG-60 Series Gel is incorporated into the electrode to improve conductivity, which is essential for reliable signal transmission during electrophysiological procedures. This enhances the accuracy and consistency of readings in EMG, EEG, and nerve conduction studies.

• Who should use this electrode?

  This electrode is intended for professional use by trained healthcare personnel in neurology-related diagnostics. It is not designed for home use or self-administration.

• What regulatory approval does the electrode hold?

  The electrode has received FDA 510(k) clearance (K915333) as substantially equivalent to a predicate device, classified under FDA product code GXY. This clearance confirms its compliance with U.S. regulatory standards for use in clinical electrophysiological procedures.