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Powerheart G5 AED

FDA 510(k)

Class III (US FDA 510(k))

510(k) K143714

by Cardiac Science Corporation

Identifiers

510(k) Number
K143714 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 G5 AED 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 combines automated voice prompts, real-time rhythm analysis, and biphasic waveform technology to guide rescuers through resuscitation procedures with precision and efficiency.

Supplied as a non-reusable, non-sterile device, the Powerheart G5 AED is intended for use in public access, workplace, and home settings by trained or untrained responders. It is classified under FDA regulation 870.5310 and holds a Traditional 510(k) clearance (K143714) with a Substantially Equivalent determination by the Cardiovascular Advisory Committee. Storage requires protection from extreme temperatures and physical damage, adhering to manufacturer guidelines for optimal performance.

Frequently asked questions

Is the Powerheart G5 AED intended for use by healthcare professionals only, or can untrained responders operate it as well?

The Powerheart G5 AED is designed for use by both trained and untrained responders, making it suitable for public access, workplace, and home settings where immediate defibrillation may be required.

How is the Powerheart G5 AED supplied, and is it meant for single-use or repeated use?

The Powerheart G5 AED is supplied as a non-reusable device, meaning it is intended for single-use only. This aligns with standard practices for AEDs to ensure reliability and safety during critical emergencies.

What storage conditions should be followed to maintain the proper functionality of the Powerheart G5 AED?

The device must be stored in a location protected from extreme temperatures and physical damage. Following the manufacturer’s guidelines ensures optimal performance and reliability when needed for emergency use.

Does the Powerheart G5 AED require sterilization before use, and if not, what does that mean for its application?

The Powerheart G5 AED is non-sterile, meaning it does not undergo sterilization before use. This design choice allows for broader accessibility, as it can be deployed quickly in public or home settings without requiring sterilization procedures.

What regulatory pathway was followed for the FDA clearance of the Powerheart G5 AED, and what does that imply for its safety and effectiveness?

The Powerheart G5 AED received a Traditional 510(k) clearance (K143714) with a Substantially Equivalent determination by the Cardiovascular Advisory Committee. This pathway confirms that the device meets FDA standards for safety and effectiveness, as it was found to be comparable to legally marketed predecessors.

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) K143714 24 fields · synced Sep 18, 2026