đź“‹ FDA Reference
Disposable Adhesive Surface Electrodes Disc Electrodes
Technomed Europe
Summary: Disposable adhesive surface electrodes are used for electrical stimulation and recording in medical procedures. They are commonly utilized by neurologists and other specialists in clinical and hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K073532 ↗
Decision Date ?
May 1, 2008
Product Code ?
GXY
Device Class ?
Class 2
Evidence ?
0 studies
The device received FDA clearance through the 510(k) pathway on May 1, 2008. It is manufactured by Technomed Europe and classified as a Class 2 device under product code GXY.
What It Is
Disposable adhesive surface electrodes are small, disc-shaped devices that adhere to the skin to conduct electrical signals. They are used in various diagnostic and therapeutic procedures, such as nerve conduction studies and electromyography. These electrodes are designed to be single-use to maintain hygiene and prevent cross-contamination.
FDA-Cleared Indications
- For surface recording of electrical activity from muscles and nerves during diagnostic procedures.
- For surface electrical stimulation of nerves and muscles during medical procedures.
- For use with compatible electromyography, nerve conduction, and electrical stimulation equipment.
Clinical Applications
- Recording muscle and nerve electrical activity during electromyography procedures.
- Recording nerve responses during nerve conduction studies.
- Delivering surface electrical stimulation during procedures involving nerves or muscles.
- Use in clinical and hospital settings when a disposable adhesive surface electrode is required for electrical recording or stimulation.
Practical Considerations
- Available electrode sizes may vary; selection depends on the anatomy, recording or stimulation technique, and patient size.
- Use only with compatible recording or stimulation equipment and follow the electrode and equipment instructions.
- Clean and prepare the skin as directed to improve adhesion and electrical signal quality.
- These electrodes are intended for single use and should not be reused because reuse can reduce performance and increase cross-contamination risk.
- MRI compatibility is not established by the information provided. Remove the electrodes before MRI unless the specific product labeling confirms that they are safe for the planned MRI conditions.
Frequently Asked Questions
What is disposable adhesive surface electrodes used for?
They are used for electrical stimulation and recording in diagnostic and therapeutic procedures, such as nerve conduction studies and electromyography.
What specialties typically use this device?
Neurology, physical therapy, and rehabilitation medicine commonly use these electrodes.
What are the FDA-cleared indications?
The electrodes are indicated for use in procedures requiring electrical stimulation or recording of muscle and nerve activity, particularly in neuromuscular assessments.
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.