Zoll Reviver

• • Terminated Z-1000-03 FDA Unclassified (pre-2012) ·initiated 23 Jun 2003

  Defibrillator may fail to charge or hold its charge above energies of 75 joules

510(k) Number

K972241 ↗

FDA product code

MKJ

Device class

Class III

Regulation

21 CFR Part 870.5310

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

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See all devices from Zoll Medical Corporation →

• What types of settings is the Zoll Reviver intended for and how does it differ from other defibrillators in those environments?

  The Zoll Reviver is specifically designed for pre-hospital, emergency medical, and public-access settings where sudden cardiac arrest may occur. Unlike wearable defibrillators, it is a non-wearable device, meaning it is not intended to be continuously carried by an individual but rather deployed in fixed or mobile locations like ambulances, fire stations, or public spaces. Its key feature is the combination of automated defibrillation with CPR guidance—providing voice prompts and visual feedback—to assist responders, even those without extensive training, in performing effective resuscitation.

• Is the Zoll Reviver reusable, and if so, what does that mean for maintenance and cleaning?

  Yes, the Zoll Reviver is a reusable device, meaning it is built to be used repeatedly across multiple patients after proper cleaning and maintenance. Since it is not intended for sterile procedures or implantation, sterility is not a requirement. However, it must be cleaned and disinfected according to manufacturer guidelines after each use to ensure proper functionality and prevent cross-contamination, particularly for electrodes and other patient-facing components.

• Are there different models or sizes available for the Zoll Reviver, and how would I determine which one is best for my application?

  The Zoll Reviver comes in multiple model variants, all listed under the product code MKJ, but the data does not specify distinct sizes or configurations beyond the core functionality. If you require specific features like battery life, weight, or additional connectivity options, you would need to consult Zoll Medical Corp’s detailed product specifications or contact their support team. Most variants are likely designed to meet general pre-hospital and public-access needs, so compatibility depends on your environment’s requirements.

• How is the Zoll Reviver regulated, and what does the FDA clearance under 510(k) mean for its use?

  The Zoll Reviver holds FDA clearance under the 510(k) pathway, which means it has been determined to be substantially equivalent to a legally marketed device already on the market. This classification applies to Class III medical devices, which are subject to stringent regulatory oversight to ensure safety and effectiveness. The clearance under regulation number 870.5310 confirms it meets FDA standards for automated external defibrillators (non-wearable), allowing its use in pre-hospital, emergency, and public-access settings as described.

• Does the Zoll Reviver have any special storage requirements, and can it be used in environments with magnetic resonance imaging (MRI) equipment?

  The Zoll Reviver does not appear to have specific MRI safety classification information provided, meaning it may not be explicitly labeled as MRI-safe or MRI-conditional. For storage, while no special conditions like temperature or humidity are mentioned, it should be kept in a clean, dry environment away from direct sunlight and extreme temperatures to preserve functionality. If used near MRI equipment, caution is advised until confirmed compatibility is established with Zoll Medical Corp.