Identifiers
- 510(k) Number
- K122758 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 automated shock therapy for victims of sudden cardiac arrest. It analyzes heart rhythms and provides voice prompts to guide rescuers through resuscitation procedures, including CPR feedback and shock delivery as clinically indicated.
Supplied as a reusable device, the Powerheart G5 AED is intended for use in public access, pre-hospital, and healthcare settings. It operates with single-use adult, pediatric, and infant pads and requires no external power source beyond its internal battery. The device adheres to FDA 510(k) clearance under the classification of Class III medical devices, with regulatory compliance under 870.5310.
Frequently asked questions
What types of settings is the Powerheart G5 AED intended for use in and why does this matter for my organization?
The Powerheart G5 AED is designed for use in public access, pre-hospital, and healthcare settings. This versatility ensures it can be deployed in locations where sudden cardiac arrest may occur, such as public spaces, emergency response teams, hospitals, and clinics. Its portability and automated features make it suitable for environments where trained personnel may not always be immediately available, helping to bridge the critical time gap between collapse and defibrillation.
Are the pads for the Powerheart G5 AED single-use or reusable, and how does this affect my supply chain?
The Powerheart G5 AED uses single-use adult, pediatric, and infant pads. This design ensures sterility and reduces the risk of cross-contamination between patients, which is critical for infection control. For your supply chain, this means you’ll need to stock replacement pads regularly and dispose of used ones properly, but it eliminates the need for cleaning or reprocessing between uses.
Does the Powerheart G5 AED require any external power source, and if not, how long does its internal battery last?
The Powerheart G5 AED operates entirely on its internal battery and does not require an external power source. While the data does not specify battery life directly, its design as a portable, standalone defibrillator implies it is built for extended use in field or public-access scenarios. For exact runtime, refer to the manufacturer’s user manual or technical specifications, as this may vary based on usage patterns (e.g., number of shocks delivered).
What regulatory pathway was followed for the FDA clearance of the Powerheart G5 AED, and how does this impact its classification?
The Powerheart G5 AED received FDA clearance through a 510(k) submission, classified as Substantially Equivalent (SE) under the Cardiovascular advisory committee. It is categorized as a Class III medical device, which typically requires stringent premarket approval due to its high-risk nature (e.g., life-saving interventions like defibrillation). This clearance indicates the device meets FDA standards for safety and effectiveness, though your organization should verify compliance with current regulations before procurement.
How does the Powerheart G5 AED guide rescuers during resuscitation, and what features make it user-friendly for untrained personnel?
The Powerheart G5 AED provides voice prompts to guide rescuers through resuscitation procedures, including CPR feedback and shock delivery when clinically indicated. This hands-free, step-by-step guidance is particularly valuable for untrained bystanders or first responders, as it reduces cognitive load during an emergency. The automated rhythm analysis ensures timely intervention without requiring advanced medical knowledge, which is critical in saving lives during sudden cardiac arrest.
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 G5 AED Defibrillator - American AED, Cardiac Science Powerheart G5 AED Defibrillator - AED Brands, Cardiac Science Powerheart G5 AED Health Care Package
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122758 | Class III | Active |
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Manufacturer
- Manufacturer
- Cardiac Science Corporation
Sources (1)
- FDA 510(k) K122758 24 fields · synced Oct 6, 2026