Elec. Cir. Pace. Mo. Li-2, Li-3, Li-4, Li-5

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

510(k) Number

K761237 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Arco Medical Products Co. →

• What types of heart conditions is this pacemaker designed to address, and how does it work?

  This device is specifically designed to manage bradycardia or conduction disorders by regulating heart rhythm. It functions as an external circuit pacemaker, delivering controlled electrical impulses to the heart muscle to ensure consistent and proper contractions, maintaining a steady cardiac rhythm.

• Is this device intended for single-use or can it be reused in multiple patients?

  The Electrical Circuit Pacemaker Model LI-2, LI-3, LI-4, and LI-5 is classified as a reusable medical device. This means it is intended for use in multiple patients within a cardiovascular setting, provided proper cleaning, maintenance, and sterilization protocols are followed.

• What regulatory pathway was followed for this device, and which advisory committee reviewed it?

  This device received FDA clearance through a 510(k) submission, specifically under the product code DXY, and was deemed substantially equivalent to a predicate device. The review was conducted by the Cardiovascular (CV) Advisory Committee, ensuring its compliance with regulations under 21 CFR 870.3610.

• Are there multiple models available, and how would I identify the correct one for my needs?

  Yes, there are five models available: LI-2, LI-3, LI-4, and LI-5. While the exact specifications for each model are not detailed in the provided data, the device is intended for pacing applications in cardiovascular settings. The correct model would depend on clinical requirements and compatibility with existing systems, so consulting the manufacturer’s documentation or a specialist is recommended.

• What is the storage requirement for this reusable pacemaker, and how should it be maintained?

  Since this device is reusable, it must be stored and maintained in accordance with established medical device reprocessing guidelines to ensure sterility and functionality. The manufacturer’s instructions should be followed for cleaning, sterilization, and storage conditions to prevent contamination or damage, ensuring safe and effective reuse in clinical settings.