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Powerheart AED G3A

FDA 510(k)

Class III (US FDA 510(k))

510(k) K040438

by Cardiac Science Corporation

Identifiers

510(k) Number
K040438 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 AED G3A is an Automated External Defibrillator (Non-Wearable), designed to deliver life-saving electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. It provides voice prompts and visual guidance to assist untrained responders in performing cardiopulmonary resuscitation (CPR) and defibrillation, enhancing the likelihood of survival during out-of-hospital cardiac events.

This device is intended for single-use or reusable applications in public and clinical settings, including hospitals, workplaces, and public spaces. Supplied as a standalone unit, it requires no additional sterilization and is classified as Class III under FDA regulations. The Powerheart AED G3A has received FDA 510(k) clearance and is regulated under the device classification K040438, adhering to strict medical device standards for safety and performance.

Frequently asked questions

Can the Powerheart AED G3A be reused after a single use, or is it strictly single-use only?

The Powerheart AED G3A is designed for both single-use and reusable applications, depending on the setting and protocol. Since it is not required to undergo sterilization (as it is not a sterile device), it can be reused in clinical or public environments where proper maintenance and recalibration are performed. However, single-use is also an option, particularly in public spaces where ease of disposal and infection control may be preferred.

How does the Powerheart AED G3A guide untrained responders during a cardiac emergency, and what features make it user-friendly?

The Powerheart AED G3A provides voice prompts and visual guidance to assist untrained responders in performing CPR and defibrillation. These features simplify the process for non-medical personnel, ensuring proper shock delivery and chest compression techniques, which are critical for improving survival rates during sudden cardiac arrest.

What types of environments is the Powerheart AED G3A intended for, and how is it typically supplied?

The Powerheart AED G3A is intended for public and clinical settings, including hospitals, workplaces, and public spaces like airports or shopping centers. It is supplied as a standalone unit, meaning no additional equipment or accessories are required for basic operation. This makes it highly portable and easy to deploy in emergency situations.

What regulatory pathway was followed for FDA clearance of the Powerheart AED G3A, and what does this mean for its safety standards?

The Powerheart AED G3A received FDA 510(k) clearance through a traditional review process, with a decision classification of *Substantially Equivalent* (SESE) under the advisory committee *Cardiovascular (CV)*. This means the device was determined to be at least as safe and effective as a legally marketed predicate device, adhering to strict FDA Class III standards for automated external defibrillators (non-wearable).

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 Powerheart AED G3 Instructions For Use Manual, Cardiac Science Powerheart AED G3, CARDIAC SCIENCE AED | Cardio Care USA, Cardiac Science Powerheart AED - G3 Plus, G3 Pro & G5 - American AED

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) K040438 24 fields · synced Sep 18, 2026