Smart Bilectrodes

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K791006 ↗

FDA Product Code

DRX

Device Class

Class II

Regulation

21 CFR Part 870.2360

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Are the Smart Bilectrodes designed for single-use or repeated applications, and what maintenance is required between uses?

  The Smart Bilectrodes are not single-use and are explicitly designed for repeated clinical applications. Since they are reusable, they must be thoroughly cleaned and sterilized between uses to ensure hygiene and proper functionality. This aligns with their classification as a reusable electrode (product code DRX) for electrocardiography (ECG) in settings like hospitals and cardiac care units.

• What clinical settings or environments are the Smart Bilectrodes intended for, and why?

  The Smart Bilectrodes are intended for clinical settings such as hospitals and cardiac care units, as stated in their description. This is because they are used in electrocardiography (ECG) to record heart electrical activity, requiring controlled environments where patient monitoring and diagnostic accuracy are critical. Their reusable design further supports frequent use in these high-stakes settings.

• How are the Smart Bilectrodes regulated, and what does their FDA clearance status indicate?

  The Smart Bilectrodes hold FDA 510(k) clearance (K791006), classified as substantially equivalent (SESE) under the Traditional clearance type. This means the device was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee and determined to meet regulatory standards for Class II medical devices, ensuring safety and performance for their intended use in ECG monitoring.

• What type of electrode configuration do the Smart Bilectrodes use, and how does this differ from standard ECG electrodes?

  The Smart Bilectrodes are specifically designed as bilectrodes, meaning they consist of paired electrodes that attach to the patient’s skin. This paired configuration allows them to capture and transmit cardiac signals more effectively for diagnostic ECG assessments, distinguishing them from single-electrode designs commonly used in traditional ECG monitoring.