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Powerheart AED G3, Model 9300

FDA 510(k)

Class III (US FDA 510(k))

510(k) K031987

by Cardiac Science Corporation

Identifiers

510(k) Number
K031987 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 G3, Model 9300 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.

This device is intended for single-use or reusable applications in pre-hospital, emergency, and public access settings, depending on configuration. Supplied as a Class III medical device under FDA 510(k) clearance (K031987), it operates in environments where defibrillation may be required, including public spaces, workplaces, and emergency response vehicles. Sterility and MRI safety are not applicable, and storage conditions are specified in the accompanying instructions.

Frequently asked questions

Can this device be reused, or is it strictly for single-use applications only?

The Powerheart AED G3, Model 9300 is designed for both single-use and reusable applications, depending on the configuration and setting. It is suitable for pre-hospital, emergency, and public access environments where defibrillation may be required. Check the manufacturer’s instructions for specific reuse guidelines, as they may vary based on usage context and maintenance protocols.

What types of environments is this defibrillator intended for, and how does that affect its use?

This device is intended for public spaces, workplaces, and emergency response vehicles where sudden cardiac arrest may occur. Its design supports untrained responders through voice prompts and visual guidance, making it ideal for settings where immediate defibrillation is critical but trained personnel may not always be available. The reusable configuration also allows for deployment in high-traffic or frequently accessed areas.

How should the Powerheart AED G3 be stored, and are there any special handling requirements?

Storage conditions for the Powerheart AED G3 are outlined in the accompanying instructions provided by Cardiac Science. While the device is not sterile and does not require MRI-safe handling, proper storage—such as in a dry, temperature-controlled environment—is essential to maintain functionality. Avoid exposure to extreme temperatures, moisture, or physical damage, as these could compromise performance.

What distinguishes this model from other automated external defibrillators in terms of regulatory approval?

The Powerheart AED G3, Model 9300, holds FDA 510(k) clearance (K031987) under a special classification as a Class III medical device, with a decision described as *Substantially Equivalent* to predicate devices. This clearance was granted through the Cardiovascular (CV) advisory committee, ensuring compliance with U.S. regulatory standards for defibrillators. The approval reflects its design for use in both pre-hospital and public-access scenarios.

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 9300E, 9300A AED Operation and ..., Cardiac Science G3 9300E, G3 9300A AED Operation and Service Manual, Cardiac science Powerheart AED G3 Manuals | ManualsLib

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cardiac Science Corporation
FDA Applicant
Cardiac Science

Sources (1)

  • FDA 510(k) K031987 24 fields · synced Oct 6, 2026