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Wet Gel ECG Electrode

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K083148

by Bio Protech Inc.

Identifiers

510(k) Number
K083148 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 Wet Gel Electrodes for Electrocardiography (DRX), designed for attaching to the skin to detect and transmit electrical signals from the heart. It facilitates the recording of ECG waveforms by maintaining consistent electrical contact through a conductive gel, ensuring accurate diagnostic readings during cardiac monitoring or evaluation.

The Wet Gel ECG Electrode is supplied as a single-use, non-sterile disposable item, intended for use in clinical settings such as hospitals, cardiac care units, or outpatient diagnostic facilities. Each electrode features a reusable adhesive backing for secure placement and is compatible with standard ECG monitoring systems. Authorized under FDA 510K and MDR, it adheres to regulatory standards for cardiovascular diagnostic devices, with a K-number K083148 for traceability.

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

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio Protech Inc.
FDA Applicant
Bio Protech, Inc.

Sources (2)

  • FDA 510(k) K083148 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026