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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
510K
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.
Clinical Applications
These electrodes are commonly used in neurology for procedures like nerve conduction studies and electromyography to assess nerve and muscle function. They are also used in physical therapy and rehabilitation settings for muscle stimulation. The device is suitable for use in both outpatient clinics and hospital environments, catering to a wide range of patient populations, including those with neuromuscular disorders.
Indications for Use
The FDA indications suggest that these electrodes are intended for use in procedures that require electrical stimulation or recording of muscle and nerve activity. They are suitable for patients undergoing diagnostic evaluations for neuromuscular conditions.
Practical Considerations
These electrodes are available in various sizes to fit different anatomical locations and patient needs. They are compatible with standard electromyography and nerve conduction equipment. Proper skin preparation is essential to ensure optimal adhesion and signal quality.
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.