ECG Disposable Lead Wire
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170536 FDA 510(k)
- FDA Product Code
- DSA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2900 FDA 510(k)
- Regulation Number
- 870.2900 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Cable, Transducer and Electrode, Patient (Including Connector) designed for electrocardiogram (ECG) monitoring. It facilitates the transmission of electrical signals from the patient’s skin to an ECG machine, enabling accurate cardiac rhythm assessment and diagnostic evaluation.
The ECG Disposable Lead Wire is a single-use, non-sterile device intended for clinical settings such as hospitals, cardiac care units, and emergency rooms. Supplied in sterile packaging, it adheres to FDA 510(k) and MDR regulatory standards, with a product code classification of DSA. Compatible with standard ECG systems, it requires no special storage conditions beyond protection from moisture and physical damage.
Frequently asked questions
What is the primary purpose of the ECG Disposable Lead Wire in clinical settings?
The ECG Disposable Lead Wire is designed to transmit electrical signals from a patient’s skin to an ECG machine, enabling accurate assessment of cardiac rhythm for diagnostic evaluation. It is specifically intended for use in monitoring heart activity in settings like hospitals, cardiac care units, and emergency rooms.
Is this device reusable or single-use, and how should it be handled to maintain sterility?
This device is explicitly labeled as single-use. While it is supplied in sterile packaging, it is not sterile *in-use*—meaning it is non-sterile by design for clinical applications. To preserve integrity, store it in its original packaging and protect it from moisture and physical damage, as no special storage conditions are required beyond these precautions.
What regulatory pathways has this device followed, and what does that mean for compatibility with ECG systems?
The ECG Disposable Lead Wire has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming its compliance with U.S. and EU regulatory standards. Its classification as a DSA (Diagnostic Substance and Analyte) product code and compatibility with standard ECG systems means it is designed to integrate seamlessly with existing diagnostic equipment for cardiac monitoring without requiring additional modifications.
Are there different sizes or models available for this lead wire, and how would I know which one to select?
The provided data does not specify distinct sizes or models for this lead wire, as it is described as a general-purpose disposable ECG lead. Selection would depend on the specific ECG machine’s connector compatibility and the manufacturer’s recommendations. Always verify compatibility with your system’s documentation or consult the manufacturer for guidance.
What should I do if the packaging is damaged before use?
Since the device is supplied in sterile packaging but is non-sterile for clinical use, damaged packaging compromises its intended single-use integrity. If the packaging is torn or compromised, do not use the lead wire—discard it immediately and open a new, undamaged unit to ensure proper functionality and patient safety.
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 Leadwire - , Supplier - APK, APK Technology Co., Ltd., ECG Disposable Lead wires (UDI: 06946725571965) Specs & FDA Data, ECG Disposable Lead Wire - healthcareequipment.org
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 | K170536 | Class II | Active |
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Manufacturer
- Manufacturer
- APK Technology Co., Ltd.
Sources (2)
- FDA 510(k) K170536 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026