đź“‹ FDA Reference
Neurolink Eeg EP Emg Surface Electrodes
Neuro Supplies
Summary: The Neurolink EEG EP EMG Surface Electrodes by Neuro Supplies are used for recording electrical activity in the brain and muscles. They are primarily used by neurologists and other specialists in clinical and research settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K942921 ↗
Decision Date ?
January 31, 1995
Product Code ?
GXY
Device Class ?
Class 2
Evidence ?
0 studies
The Neurolink EEG EP EMG Surface Electrodes were cleared through the FDA 510(k) pathway on January 31, 1995. Manufactured by Neuro Supplies, this device is classified as Class 2 under product code GXY.
What It Is
The Neurolink EEG EP EMG Surface Electrodes are non-invasive electrodes designed to record electrical activity from the brain (EEG), evoked potentials (EP), and muscle activity (EMG). These electrodes are placed on the skin surface and are essential tools in diagnosing and monitoring neurological and muscular disorders. They work by detecting electrical signals generated by neuronal and muscular activity, which are then amplified and analyzed.
FDA-Cleared Indications
- Recording electrical activity from the brain by electroencephalography (EEG)
- Recording evoked potentials (EP)
- Recording electrical activity from muscles by electromyography (EMG)
Clinical Applications
- EEG recording and monitoring
- Evoked-potential testing
- Surface EMG recording
- Clinical neurophysiology evaluation of brain and muscle electrical activity
- Research recording of brain and muscle signals
Practical Considerations
- These are surface electrodes and are placed on prepared skin rather than inserted into tissue.
- Available electrode sizes and configurations should be selected for the patient, recording technique, and body site.
- The electrodes should be compatible with the intended EEG, EP, or EMG recording system.
- Skin preparation and secure placement help reduce impedance and motion-related recording artifacts.
- MRI safety depends on the specific electrode materials, cables, and connected equipment; do not assume MRI compatibility without the manufacturer’s labeling.
Frequently Asked Questions
What is Neurolink EEG EP EMG Surface Electrodes used for?
These electrodes are used for recording electrical activity from the brain and muscles, aiding in the diagnosis and monitoring of neurological and muscular disorders.
What specialties typically use this device?
Neurologists, clinical neurophysiologists, and researchers commonly use these electrodes in both clinical and research settings.
What are the FDA-cleared indications?
The electrodes are indicated for recording electrical activity in the brain and muscles, useful for conditions like epilepsy, sleep disorders, and neuromuscular diseases.
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.