Electrocardiograph (ECG) Electrode, Non-Sterile
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K020003 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)
The Electrocardiograph (ECG) Electrode, Non-Sterile is a single-use, disposable medical device designed for recording the electrical activity of the heart. It features a silver/silver chloride (Ag/AgCl) sensing element paired with a solid adhesive hydrogel to ensure low impedance and minimize movement artifact during monitoring.
These electrodes are intended for short-term diagnostic resting ECG use and are supplied in a non-sterile configuration. They are self-adhesive, adhering directly to the patient’s skin to provide stable signal tracing. The device is regulated under FDA 510(k) clearance (K020003) and meets MDR requirements, ensuring compliance with cardiovascular diagnostic standards.
Frequently asked questions
Are these ECG electrodes meant for long-term monitoring or just short-term diagnostic use?
These electrodes are specifically designed for short-term diagnostic resting ECG use only, as stated in the device description. They are not intended for continuous or long-term monitoring, which requires different electrode types and configurations.
How do I know if these electrodes are suitable for my patient’s skin type, especially if they have sensitive or oily skin?
The electrodes feature a silver/silver chloride (Ag/AgCl) sensing element paired with a solid adhesive hydrogel, which helps reduce irritation and provides stable adhesion. While they are generally suitable for most skin types, if your patient has highly sensitive or oily skin, you may want to pre-clean the application site with alcohol or a mild skin prep solution to ensure optimal adhesion and signal quality.
Can these electrodes be reused, or are they strictly single-use?
These electrodes are explicitly labeled as single-use and disposable, meaning they should not be reused. Reusing them could compromise signal accuracy, introduce infection risks, or degrade performance due to adhesive degradation or contamination.
What regulatory pathways does this device follow, and how does that affect its use in clinical settings?
This device is regulated under FDA 510(k) clearance (K020003) with a substantially equivalent determination by the Cardiovascular (CV) Advisory Committee, and it also meets MDR (Medical Device Regulation) requirements. This means it has undergone review for safety and performance in cardiovascular diagnostics, ensuring compliance with U.S. and EU standards for ECG electrodes used in resting diagnostic evaluations.
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: Electrocardiograph (Ecg) Electrode, Non-sterile, Bio-Protech | Medical Electrode & Surgical Device Manufacturer, Bio-Protech ECG Electrodes - Beck-Lee, ECG Electrode : Pro-Tab - Clip On - TRIUS Medical
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 | K020003 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio Protech Inc.
- FDA Applicant
- Bio Protech, Inc.
Sources (2)
- FDA 510(k) K020003 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026