Rhythmlink International Subdermal Needle Electrodes
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K022914 FDA 510(k)
- FDA Product Code
- GXZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1350 FDA 510(k)
- Regulation Number
- 882.1350 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rhythmlink International Subdermal Needle Electrodes are classified as needle electrodes, designed for subcutaneous insertion to facilitate electrical signal transmission in neurological applications. These electrodes are intended for use in cardiac rhythm management systems, enabling precise monitoring and stimulation of cardiac activity by delivering electrical impulses through fine, insulated needles.
Supplied sterile and intended for single-use, these electrodes are regulated under FDA 510(k) clearance and EU MDR compliance. They are available in multiple reference codes (e.g., 3003495548, 3004040397) and are classified as Class II medical devices. Storage requires adherence to manufacturer guidelines to maintain sterility, and their use is governed by regulatory standards for electrical safety and biocompatibility, ensuring compatibility with MRI environments where applicable.
Frequently asked questions
What types of medical systems are these electrodes designed to work with, and why are they specifically called 'subdermal needle electrodes'?
These electrodes are designed for cardiac rhythm management systems, such as pacemakers or implantable cardioverter-defibrillators (ICDs), to enable precise monitoring and stimulation of cardiac activity. They are called *subdermal needle electrodes* because they are inserted beneath the skin (subdermally) using fine, insulated needles, allowing for stable electrical signal transmission without requiring large surface-area pads.
Are these electrodes reusable, or are they meant for single-use only? How does that affect their sterility and handling?
These electrodes are intended for single-use only and are supplied sterile to ensure patient safety. Because they are not designed for reuse, proper handling and adherence to manufacturer storage guidelines are critical to maintain sterility before use. Reusing them could compromise biocompatibility and increase infection risks.
What should I consider when storing these electrodes to ensure they remain effective and safe for use?
Storage must follow the manufacturer’s guidelines to preserve sterility and functionality. Since they are sterile and single-use, they should be kept in their original packaging until use, protected from moisture, extreme temperatures, and physical damage. Improper storage could compromise electrode integrity or introduce contamination risks.
How do I identify the correct model or reference code for these electrodes, especially since multiple codes are listed?
The electrodes are available under multiple FDA registration numbers (e.g., 3003495548, 3004040397) and product codes (e.g., GXZ). These codes correspond to specific configurations or sizes, so you should verify the exact model required by your device compatibility or clinical application. Always cross-reference with your facility’s inventory or the manufacturer’s documentation to ensure the correct electrode is ordered.
Are these electrodes compatible with MRI environments, and if so, what safety considerations should be noted?
The device data indicates these electrodes are designed with MRI compatibility in mind, though explicit MRI-safe labeling isn’t provided. If used in an MRI environment, follow strict electromagnetic interference (EMI) and safety protocols, including ensuring proper grounding and adhering to the MRI facility’s guidelines for implanted devices. Always confirm compatibility with your MRI system’s technical specifications.
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 | K022914 | Class II | Active |
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Manufacturer
- Manufacturer
- Rhythmlink International, LLC
Sources (2)
- FDA 510(k) K022914 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026