Identifiers
- 510(k) Number
- K040637 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 Pro 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 analysis of heart rhythms, and biphasic waveform technology to enhance effectiveness and ease of use for both trained responders and laypersons.
This device is intended for single-use per battery cycle and is supplied as a non-sterile, portable unit for emergency response settings. It requires no special storage conditions but must be stored in a dry, temperature-controlled environment as per manufacturer guidelines. The Powerheart AED G3 Pro holds FDA 510(k) clearance under the classification of Class III medical devices, adhering to regulatory standards for automated external defibrillators.
Frequently asked questions
Is the Powerheart AED G3 Pro designed for reuse or single-use per battery cycle, and what does that mean for maintenance?
The Powerheart AED G3 Pro is designed for single-use per battery cycle, meaning it is intended to be used once before the battery is depleted. This design eliminates the need for repeated calibration or maintenance between uses, simplifying logistics for emergency responders. However, the device itself is a reusable unit—it can be recharged and reused for subsequent battery cycles, but the battery and any disposable components (like pads) should be replaced after each use as part of standard protocol.
What storage conditions are required for the Powerheart AED G3 Pro, and why is this important?
The Powerheart AED G3 Pro does not require special storage conditions beyond keeping it in a dry, temperature-controlled environment. This ensures the device remains functional and reliable when needed, as extreme temperatures or humidity could potentially affect battery performance or internal components. The manufacturer’s guidelines emphasize this to maintain the device’s readiness for emergency use.
How does the Powerheart AED G3 Pro differ from other AEDs in terms of its technology and user experience?
The Powerheart AED G3 Pro incorporates biphasic waveform technology for delivering electrical shocks, which is designed to be more effective in restoring normal heart rhythm compared to older monophasic systems. It also features real-time rhythm analysis and automated voice prompts, making it accessible for both trained responders and laypersons. These features enhance usability and confidence in emergency situations.
What regulatory pathway was followed for the FDA clearance of the Powerheart AED G3 Pro, and what does this imply for its safety and effectiveness?
The Powerheart AED G3 Pro received FDA 510(k) clearance under the Class III medical device classification, which is the highest regulatory category for devices that support or sustain life, are of substantial importance in preventing impairment, or present a potential unreasonable risk of illness or injury. The clearance was granted through a traditional 510(k) review by the FDA’s Cardiovascular (CV) Advisory Committee, indicating that the device was deemed substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040637 | Class III | Active |
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Manufacturer
- Manufacturer
- Cardiac Science Corporation
- FDA Applicant
- Cardiac Science, Inc.
Sources (1)
- FDA 510(k) K040637 24 fields · synced Sep 18, 2026