Protab ECG Tabb Electrode
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K040784 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 Protab ECG Tabb Electrode is a disposable adhesive electrode designed for use in electrocardiogram (ECG) monitoring. It facilitates the attachment of ECG leads to the patient’s skin, enabling accurate and reliable recording of cardiac electrical activity for diagnostic purposes.
This single-use electrode is supplied sterile and intended for use in clinical settings such as hospitals, emergency rooms, and cardiac care units. It adheres securely to the skin via a tabbed design, ensuring stable signal acquisition during ECG procedures. The device complies with FDA 510(k) clearance under the product code DRX and is regulated under the Medical Device Regulation (MDR) framework.
Frequently asked questions
What clinical settings is the Protab ECG Tabb Electrode intended for use in, and why is this important for clinicians?
The Protab ECG Tabb Electrode is designed for use in clinical settings like hospitals, emergency rooms, and cardiac care units. This is important because these environments require reliable, single-use electrodes that can securely attach to a patient’s skin for accurate ECG monitoring during critical diagnostic procedures. The sterile, disposable nature of the electrode minimizes cross-contamination risks, ensuring patient safety in high-risk areas.
How does the tabbed design of the Protab ECG Tabb Electrode improve signal acquisition during ECG procedures?
The tabbed design of the Protab ECG Tabb Electrode enhances stability by providing a secure and consistent attachment to the patient’s skin. This reduces movement artifacts, which can interfere with accurate ECG readings, ensuring clearer and more reliable cardiac electrical activity recordings during monitoring.
Is the Protab ECG Tabb Electrode reusable, and if not, why is it supplied sterile?
No, the Protab ECG Tabb Electrode is a single-use device. It is supplied sterile to prevent infection transmission between patients, which is critical in clinical settings where hygiene and contamination control are paramount for patient safety and procedural integrity.
What regulatory pathways does the Protab ECG Tabb Electrode follow, and how does this affect its use in the U.S.?
The Protab ECG Tabb Electrode follows the FDA 510(k) clearance pathway under product code DRX, with a decision classified as *Substantially Equivalent* to a predicate device. This means it has been reviewed by the FDA’s Cardiovascular (CV) advisory committee and deemed compliant with safety and performance standards for ECG monitoring. Clinicians can rely on its regulatory approval for use in diagnostic ECG procedures in U.S. healthcare settings.
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 | K040784 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio Protech Inc.
- FDA Applicant
- Bio Protech, Inc.
Sources (2)
- FDA 510(k) K040784 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026