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POWERHEART AED G3 - Powerheart Aed G3 Automatic

FDA 510(k)

Class III (US FDA 510(k))

510(k) K091943

by Cardiac Science Corporation

Identifiers

510(k) Number
K091943 FDA 510(k)
FDA Product Code
MKJ FDA 510(k)
Models / Variants
9390e FDA 510(k)
Powerheart Aed G3 Automatic FDA 510(k)
Model 9390a 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 AED G3 is an Automated External Defibrillator (Non-Wearable), designed to deliver automated analysis and shock therapy for victims of sudden cardiac arrest. It provides voice prompts and visual guidance to assist bystanders in performing cardiopulmonary resuscitation (CPR) and defibrillation, increasing the likelihood of survival for the patient.

Supplied as a reusable device, the Powerheart AED G3 is intended for use in public access defibrillation programs, emergency response settings, and healthcare facilities. It is not sterile and requires proper training for operation. The device adheres to FDA clearance under 510(k) classification, with a regulatory classification of Class III (device class=3) under regulation number 870.5310. Models 9390E and 9390A are distinct variants of the same automated external defibrillator system.

Frequently asked questions

What is the primary purpose of the Powerheart AED G3, and where is it typically deployed?

The Powerheart AED G3 is an automated external defibrillator (non-wearable) designed to deliver shock therapy and guide bystanders through CPR and defibrillation for victims of sudden cardiac arrest. It is intended for use in public access defibrillation programs, emergency response settings, and healthcare facilities to increase survival rates. The device provides voice prompts and visual guidance to assist untrained responders.

Is the Powerheart AED G3 a single-use or reusable device, and what does that mean for maintenance?

The Powerheart AED G3 is a reusable device, meaning it is not intended for single-use disposal. This design allows for regular maintenance, calibration, and updates to ensure continued functionality and reliability in emergency situations. Proper training is required for operation and maintenance to comply with manufacturer guidelines.

Are there different models of the Powerheart AED G3, and how do they differ?

Yes, there are two distinct models: the Powerheart AED G3, Model 9390E, and the Powerheart AED G3 Automatic, Model 9390A. While both are automated external defibrillators, the specific differences between them are not detailed in the provided data. However, they share the same core functionality of delivering shock therapy and CPR guidance for sudden cardiac arrest victims.

How is the regulatory status of the Powerheart AED G3 determined, and what does that entail?

The Powerheart AED G3 holds FDA clearance under a 510(k) submission (K091943), classified as Class III (device class=3) under regulation number 870.5310. This classification indicates it is a high-risk medical device requiring strict regulatory oversight. The clearance was determined through a substantially equivalent review by the FDA’s Cardiovascular (CV) advisory committee, ensuring compliance with safety and performance standards for automated external defibrillators.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cardiac Science Corporation

Sources (1)

  • FDA 510(k) K091943 24 fields · synced Oct 6, 2026