Friendship Medical Disposable Pre-Gelled Ag / Agcl Surface Electrode
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K110289 FDA 510(k)
- FDA Product Code
- GXY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1320 FDA 510(k)
- Regulation Number
- 882.1320 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Disposable Pre-Gelled Ag/AgCl Surface Electrode, classified under the nomenclature for electrocardiographic and electrophysiological monitoring electrodes. It is designed for non-invasive attachment to the skin to detect and transmit electrical signals from the heart or muscles, enabling accurate monitoring of cardiac activity or neuromuscular function during clinical assessments or diagnostic procedures.
The electrode is supplied as a single-use, sterile device intended for use in clinical settings such as hospitals, outpatient clinics, or emergency care. Each electrode features a pre-applied conductive gel to ensure consistent skin contact and reliable signal transmission. Manufactured under FDA 510(k) clearance, MDD, and MDR compliance, it adheres to regulatory standards for medical devices. Storage requires protection from extreme temperatures and moisture, and proper disposal follows standard biomedical waste protocols.
Frequently asked questions
Are these electrodes reusable or intended for single-use only, and why does that matter for my clinical workflow?
These electrodes are explicitly designed for single-use only, as stated in the device description. This ensures sterility and reduces the risk of cross-contamination between patients, which is critical in clinical settings like hospitals or outpatient clinics. Single-use electrodes also eliminate the need for cleaning and reprocessing, saving time and resources while maintaining compliance with infection control protocols.
How should I store these electrodes to maintain their performance and sterility before use?
The electrodes must be stored in a dry environment protected from extreme temperatures and moisture to preserve their pre-gelled surface and sterility. Exposure to humidity or temperature fluctuations could degrade the conductive gel or compromise the sterile packaging. Always check the packaging for integrity before use, and follow standard storage guidelines for medical devices to ensure reliability during monitoring procedures.
What sizes or models are available for this electrode, and how do I know which one to select for a patient?
The provided specifications do not list specific sizes or models, but the device is described as a standard disposable pre-gelled Ag/AgCl surface electrode for electrocardiographic or electrophysiological monitoring. Typically, these electrodes come in universal or pediatric sizes, but you should confirm the exact dimensions or variants available from the manufacturer or distributor. For selection, consider the patient’s age, body size, and the specific monitoring needs (e.g., pediatric vs. adult ECG leads).
What regulatory pathways does this device follow, and does that affect how I can use it in my facility?
This device is cleared under FDA 510(k) (K110289), as well as compliant with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in the EU. The FDA clearance indicates it is deemed substantially equivalent to a predicate device, meaning it meets established safety and effectiveness standards for electrocardiographic electrodes. While this doesn’t dictate clinical indications, it confirms the device adheres to regulatory requirements for use in monitoring cardiac or neuromuscular activity. Always verify local regulations and facility protocols to ensure compliance.
Can these electrodes be used for both cardiac and neuromuscular monitoring, and what makes them suitable for each application?
Yes, these electrodes are designed for both cardiac and neuromuscular monitoring, as noted in the description. The pre-gelled Ag/AgCl surface ensures consistent skin contact and reliable signal transmission, which is essential for accurately capturing electrical signals from the heart (e.g., ECG) or muscles (e.g., electromyography). The conductive gel reduces impedance between the electrode and skin, improving signal clarity for diagnostic assessments in either application. However, always follow manufacturer guidelines for specific monitoring protocols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K110289 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xi'an Friendship Medical Electronics Co., Ltd.
- FDA Applicant
- Xian Friendship Medical Electronics Co., Ltd.
Sources (2)
- FDA 510(k) K110289 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026