Modified Jeltrode Electrodes

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Modified Jeltrode(Tm) Electrodes Deemed

510(k) Number

K884348 ↗

FDA Product Code

GXY

Device Class

Class II

Regulation

21 CFR Part 882.1320

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Jeltrode

  Class II

  FDA 510(k) K861956 Active Cleared 26 Jun 1986

• Am Tm Syrgical Drapes

  Class II

  FDA 510(k) K882643 Active Cleared 3 Mar 1989

• Endomed CV405

  Class II

  FDA 510(k) K880699 Active Cleared 2 May 1988

• Computerized Testing and Exercise Systems

  Class I

  FDA 510(k) K926313 Active Cleared 4 Feb 1994

• Monotrode Cutaneous Electrode

  Class II

  FDA 510(k) K915864 Active Cleared 21 Jul 1993

• Model T11 Fluidotherapy Unit

  Class II

  FDA 510(k) K896817 Active Cleared 18 Jan 1991

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• What are the Modified Jeltrode Electrodes used for?

  The Modified Jeltrode Electrodes are specifically designed for neurological diagnostic procedures, particularly electroencephalography (EEG). They are used to record electrical activity from the brain, enabling accurate monitoring of brain wave patterns. The design modifications improve signal clarity and enhance patient comfort during extended monitoring sessions, making them ideal for clinical settings where prolonged EEG recordings are required.

• Are the Modified Jeltrode Electrodes single-use or reusable?

  The Modified Jeltrode Electrodes are supplied as single-use devices. This design ensures hygiene and reduces the risk of cross-contamination between patients, which is critical in clinical and diagnostic settings. After use, they must be disposed of following standard biohazard protocols for single-use medical devices.

• What storage conditions are required for these electrodes?

  To maintain their integrity, the Modified Jeltrode Electrodes must be stored in a way that protects them from moisture and extreme temperatures. Proper storage ensures the electrodes remain effective for their intended use in EEG monitoring. Always follow manufacturer guidelines for optimal shelf life and performance.

• Are the Modified Jeltrode Electrodes sterile?

  No, the Modified Jeltrode Electrodes are non-sterile. They are intended for clinical use in hospital or diagnostic center settings where sterility is not required for the procedure. However, proper hygiene practices should still be followed to minimize infection risks during application.

• How are these electrodes classified and regulated?

  The Modified Jeltrode Electrodes are classified under product code GXY and have been deemed substantially equivalent through an FDA 510(k) clearance (K884348). This classification was reviewed by the Neurology Advisory Committee and falls under the traditional clearance type, ensuring compliance with regulatory standards for neurological diagnostic devices.