Disposable ECG Monitoring Electrode #4600 60MM, #4610 45MM
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K950479 FDA 510(k)
- FDA Product Code
- DRX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2360 FDA 510(k)
- Regulation Number
- 870.2360 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a disposable ECG monitoring electrode, classified under the FDA’s product code DRX for cardiovascular applications. It is designed for single-use attachment to the skin to detect and transmit electrical signals from the heart, enabling continuous electrocardiographic monitoring. The electrodes feature two sizes—60mm (#4600) and 45mm (#4610)—to accommodate varying patient anatomies and clinical needs. Their adhesive and conductive properties ensure reliable signal capture during diagnostic or procedural monitoring.
The electrodes are intended for single-use only and are supplied sterile in sealed packaging for immediate clinical use. They are not MRI-compatible and must be removed prior to MRI procedures. Storage requires protection from extreme temperatures and moisture, adhering to standard sterile supply protocols. Authorized for commercial distribution in the U.S. under FDA 510(k) clearance (K950479), this device meets regulatory standards for cardiovascular monitoring equipment as defined by the FDA’s Substantially Equivalent determination.
Frequently asked questions
What is the purpose of the Nikomed disposable ECG electrodes (#4600, #4610)?
These electrodes are designed for single-use attachment to the skin to detect and transmit electrical signals from the heart. They enable continuous electrocardiographic monitoring during diagnostic procedures or clinical observations, ensuring accurate heart activity tracking for patient assessment.
How are the electrodes supplied, and what does this mean for clinical use?
The electrodes are supplied sterile in sealed packaging, ensuring immediate clinical readiness without additional preparation. This sterile packaging guarantees contamination-free application, which is critical for accurate ECG readings and patient safety during monitoring.
Are these electrodes reusable, and if not, why?
No, these electrodes are intended for single-use only. Their adhesive and conductive properties are optimized for one-time application to maintain signal reliability. Reuse could compromise sterility, signal accuracy, and patient safety, making single-use the recommended practice.
What sizes are available, and how do they differ?
Two sizes are available: #4600 (60mm) and #4610 (45mm). The larger size (#4600) may be better suited for adults or patients with broader chest anatomy, while the smaller size (#4610) accommodates pediatric or smaller adult patients, ensuring proper adhesion and signal capture for varied clinical needs.
What storage conditions are required for these electrodes?
Storage must protect the electrodes from extreme temperatures and moisture to preserve sterility and functionality. Following standard sterile supply protocols—such as keeping them in a dry, sealed environment at room temperature—ensures they remain ready for immediate clinical use when needed.
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. Sources consulted: Disposable Ecg Monitoring Electrode #4600 60mm, #4610 45mm (K950479 ..., Disposable Ecg Monitoring Electrode #4600 60mm, #4610 45mm, Home - Nikomed, Monitoring Electrodes - Nikomed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K950479 | Class II | Active |
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Manufacturer
- Manufacturer
- Nikomed U.s.a., Inc.
Sources (1)
- FDA 510(k) K950479 24 fields · synced Oct 5, 2026