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friendship medical disposable pre-gelled ag agcl surface electrode
Xian Friendship Medical Electronics
Summary: The Friendship Medical Disposable Pre-Gelled Ag AgCl Surface Electrode is a medical device used for monitoring electrical activity in the body, commonly in ECG and EEG applications. It is used by healthcare professionals in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K110289 ↗
Decision Date
August 30, 2011
Product Code
GXY
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510k pathway on August 30, 2011. Manufactured by Xian Friendship Medical Electronics, it is classified as a Class 2 device under product code GXY.
What It Is
The Friendship Medical Disposable Pre-Gelled Ag AgCl Surface Electrode is a single-use electrode that utilizes silver/silver chloride (Ag/AgCl) for optimal conductivity. It is pre-gelled, which simplifies application and ensures consistent contact with the skin. These electrodes are crucial in capturing bioelectrical signals for diagnostic and monitoring purposes.
Clinical Applications
These electrodes are commonly used in cardiology and neurology for procedures such as electrocardiograms (ECG) and electroencephalograms (EEG). They are suitable for use in hospitals, outpatient clinics, and during emergency transport. The device is applicable for both adult and pediatric patient populations, providing versatility in various clinical scenarios.
Indications for Use
FDA indications suggest this device is used for recording electrical activity in the body, such as heart rhythms or brain waves. It is suitable for patients requiring cardiac or neurological monitoring.
Practical Considerations
These electrodes are typically available in various sizes to accommodate different patient needs. They are compatible with standard monitoring equipment and are designed for easy application and removal. Clinicians should ensure proper skin preparation to optimize signal quality.
Frequently Asked Questions
What is the Friendship Medical Disposable Pre-Gelled Ag AgCl Surface Electrode used for?
It is used for monitoring electrical activity in the body, such as in ECG and EEG tests.
What specialties typically use this device?
Cardiology and neurology specialties commonly use this device for monitoring heart and brain activity.
What are the FDA-cleared indications?
The device is indicated for recording bioelectrical signals, such as heart rhythms and brain waves, in patients requiring monitoring.
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.