Life Defense Plus Defibrillator/Monitor/Pacer

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

Full name

Life Defense Plus(Tm), Defibrillator/Monitor/Pacer

510(k) Number

K895533 ↗

FDA Product Code

LDD

Device Class

Class II

Regulation

21 CFR Part 870.5300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Matrix Medica, Inc. →

• What is the primary purpose of the Life Defense Plus defibrillator?

  The Life Defense Plus is designed to restore normal heart rhythm or terminate life-threatening arrhythmias in the atria or ventricles by delivering controlled electrical shocks of up to 360 joules. It combines defibrillation, cardiac monitoring, and temporary pacing in one device, making it ideal for emergency interventions in clinical and pre-hospital environments.

• Is the Life Defense Plus a single-use or reusable device?

  The Life Defense Plus is a reusable medical device. It requires regular calibration, maintenance, and cleaning according to manufacturer guidelines and institutional protocols to ensure reliable performance and patient safety. Sterility is not a requirement for this device.

• What energy range does the Life Defense Plus defibrillator operate within?

  The device delivers electrical shocks within a defined range, specifically up to 360 joules, to provide targeted intervention while minimizing risk to the patient. This low-energy design helps ensure precision during emergency cardiac procedures.

• How should the Life Defense Plus be stored and maintained?

  Since the Life Defense Plus is reusable, it must be stored in a clean, dry environment as specified by the manufacturer. Regular maintenance, including calibration and servicing, is required to ensure proper functionality. Follow institutional protocols and regulatory guidelines to maintain sterility and reliability before each use.

• What regulatory clearance does the Life Defense Plus hold?

  The Life Defense Plus holds FDA 510(k) clearance (K895533) under the Cardiovascular advisory committee, classified as a Class II device under regulation 870.5300. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory standards for defibrillators.