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electrode surface eeg electrode
Durden Enterprises
Summary: The electrode surface EEG electrode by Durden Enterprises is used for recording electrical activity in the brain. Key evidence highlights its role in measuring high-frequency oscillations, which are important in epilepsy prognosis.
FDA Clearance Information
Pathway
510K
Number
K842271 ↗
Decision Date
July 20, 1984
Product Code
GXY
Device Class
Class 2
Evidence
0 studies
The electrode surface EEG electrode was cleared by the FDA via the 510(k) pathway on July 20, 1984. It is manufactured by Durden Enterprises and classified as a Class 2 device.
What It Is
This device is a surface electrode used in electroencephalography (EEG) to measure electrical activity in the brain. It is intended for clinical use in diagnosing and monitoring neurological conditions.
Clinical Applications
Commonly used in the diagnosis and management of epilepsy, the electrode surface EEG electrode is also employed in research settings to study brain activity. It is particularly useful in detecting high-frequency oscillations.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs and case series, conducted between 2021 and 2024. These studies explore the impact of electrode design on EEG measurements.
Reported Outcomes
Published studies report that electrode surface area significantly impacts the measurement of high-frequency oscillations in EEG, which are crucial in epilepsy prognosis. Other studies highlight the potential of novel electrode designs in improving EEG signal quality.
Safety Profile
Reported complications include challenges in electrode placement and potential discomfort during prolonged use. However, no severe adverse events have been documented in the reviewed studies.
Evidence Limitations
The evidence is limited by the variability in study designs and small sample sizes. Further research is needed to standardize electrode design and placement to optimize EEG measurements.
Frequently Asked Questions
What are the clinical indications for electrode surface EEG electrode?
The device is indicated for use in recording brain electrical activity, particularly in diagnosing and managing epilepsy.
What outcomes have been reported in clinical studies?
Studies have reported that electrode surface area affects the measurement of high-frequency oscillations, which are important in epilepsy prognosis.
What complications have been reported?
Safety data indicate potential discomfort and challenges in electrode placement, but no severe adverse events have been reported.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.