Surface Electrode for Electroencephalography

FDA-Cleared Indications

• Recording electrical activity from the brain through scalp electrodes during an electroencephalogram (EEG).

Clinical Applications

• Routine or prolonged EEG recording in clinical settings
• Monitoring brain-wave activity during neurological evaluation
• Use as part of EEG-based assessment when directed by a qualified clinician

Reported off-label uses

• Research recording of high-frequency EEG oscillations as potential biomarkers in epilepsy
• Research and clinical monitoring applications involving quantitative EEG analysis

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The electrode must be applied to the scalp with appropriate conductive material and securely connected to compatible EEG recording equipment.
• Skin preparation may be needed to reduce impedance and improve signal quality; the skin should be checked for irritation after removal.
• This is an external recording electrode and does not penetrate the skull or brain.
• MRI compatibility depends on the specific electrode construction, lead wires, and connected EEG system; verify labeling before MRI exposure.
• Avoid use on damaged or infected scalp skin unless specifically directed by a clinician.