Silver Conductive Electrodes
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171721 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)
The Silver Conductive Electrodes are classified as a neurological electrode designed for surface electromyography (sEMG) and electroencephalography (EEG) applications. These electrodes facilitate the recording of electrical activity from muscles or the brain by providing a conductive interface between the skin and measurement equipment, ensuring accurate signal transmission for diagnostic or monitoring purposes.
These electrodes are supplied as single-use, non-sterile devices intended for use in clinical or research settings where electrical signal acquisition is required. They are compatible with standard EEG and EMG systems and must be stored in a clean, dry environment to maintain conductivity. The product is authorised under FDA 510K clearance and MDR, adhering to regulatory standards for medical electrical equipment.
Frequently asked questions
Are these electrodes reusable, or are they meant to be used only once?
These electrodes are explicitly labeled as single-use, meaning they should not be reused after one application. This designation aligns with their non-sterile classification, which is typical for disposable medical devices used in clinical or research settings where hygiene and signal integrity are prioritized.
How should I store these electrodes to ensure they remain functional?
The electrodes must be stored in a clean, dry environment to preserve their conductivity. Moisture or contamination could compromise the silver conductive surface, leading to poor signal transmission during use. Avoid exposure to extreme temperatures or direct sunlight.
What types of diagnostic equipment are these electrodes compatible with?
These electrodes are designed for surface electromyography (sEMG) and electroencephalography (EEG) applications. They are compatible with standard systems used for recording electrical activity from muscles or the brain, ensuring accurate signal transmission for diagnostic or monitoring purposes.
Are these electrodes sterile, and if not, what precautions should I take when using them?
The electrodes are non-sterile and intended for use in clinical or research settings where standard hygiene practices apply. Since they are single-use, proper hand hygiene and skin preparation (e.g., cleaning the application site) are recommended before use to minimize infection risk.
What regulatory pathways have these electrodes gone through, and how does that affect their use?
These electrodes have received FDA 510(k) clearance and comply with MDR (Medical Device Regulation) standards. The clearance under the FDA’s 510(k) pathway confirms they are deemed substantially equivalent to a legally marketed predicate device, ensuring they meet safety and performance requirements for neurological electrode applications.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K171721 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Konmed Technology Co., Ltd.
Sources (2)
- FDA 510(k) K171721 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026