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Powerheart Cardiac Rhythm Module

FDA 510(k)

Class III (US FDA 510(k))

510(k) K012197

by Cardiac Science Corporation

Identifiers

510(k) Number
K012197 FDA 510(k)
FDA Product Code
MKJ FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 870.5310 FDA 510(k)
Regulation Number
870.5310 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Powerheart Cardiac Rhythm Module is an Automated External Defibrillator (Non-Wearable) designed to analyze cardiac rhythms and deliver synchronized cardioversion or defibrillation shocks. It is intended for use in emergency situations to restore normal heart rhythm in patients experiencing sudden cardiac arrest or life-threatening arrhythmias, such as ventricular fibrillation or pulseless ventricular tachycardia.

This device is supplied as a reusable component integrated into a defibrillator system and is regulated under FDA 510(k) clearance (K012197) as substantially equivalent to predicate devices. It is intended for use in pre-hospital, clinical, and public-access settings, adhering to MRI safety guidelines for non-ferromagnetic materials. The module is part of a Class III medical device and requires proper training for operation, maintenance, and storage in accordance with manufacturer instructions.

Frequently asked questions

Is the Powerheart Cardiac Rhythm Module designed for single-use or can it be reused in multiple emergency situations?

The Powerheart Cardiac Rhythm Module is a reusable component intended to be integrated into a defibrillator system. It is not designed for single-use and is meant to be used repeatedly in emergency situations, provided it undergoes proper maintenance and adheres to manufacturer guidelines.

What types of environments or settings is this device intended for use?

The Powerheart Cardiac Rhythm Module is designed for use in pre-hospital, clinical, and public-access settings. It is suitable for emergency situations where immediate intervention is required to restore normal heart rhythm in patients experiencing sudden cardiac arrest or life-threatening arrhythmias.

How is the device regulated, and what does that mean for its use?

The Powerheart Cardiac Rhythm Module is regulated under the FDA 510(k) clearance process, specifically classified as substantially equivalent to predicate devices. This means it has been reviewed by the FDA and deemed comparable to existing devices in terms of safety and effectiveness. It is categorized as a Class III medical device, which typically requires strict regulatory oversight due to its critical role in life-saving situations.

Does this device require any special handling or storage conditions?

While the device data does not specify exact storage conditions, as a reusable component of a Class III medical device, the Powerheart Cardiac Rhythm Module must be stored and maintained according to the manufacturer’s instructions. This includes proper handling to ensure functionality, adherence to MRI safety guidelines for non-ferromagnetic materials, and regular maintenance to guarantee reliability in emergency situations.

What types of arrhythmias is this device intended to treat?

The Powerheart Cardiac Rhythm Module is designed to analyze cardiac rhythms and deliver synchronized cardioversion or defibrillation shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest or life-threatening arrhythmias, specifically ventricular fibrillation or pulseless ventricular tachycardia.

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. Sources consulted: CARDIAC SCIENCE AED | Cardio Care USA, PDF Cardiac Science Powerheart G3 Plus AED Manual - Heartsmart, PDF The Powerheart AED Family of Products - AED Brands, Cardiac Science Powerheart g5 Aed Manual | PDF - Scribd

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cardiac Science Corporation
FDA Applicant
Cardiac Science, Inc.

Sources (1)

  • FDA 510(k) K012197 24 fields · synced Sep 18, 2026