Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G…
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K102496 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 series are automated external defibrillators (non-wearable), designed to deliver life-saving electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. These devices provide voice prompts and visual guidance to assist untrained responders in performing cardiopulmonary resuscitation (CPR) and defibrillation, ensuring rapid intervention during emergencies.
The Powerheart AED G3 models are intended for single-use or reusable applications, depending on the variant, and are regulated under FDA 510(k) clearance (K102496) as Class III medical devices. They are supplied as portable, non-wearable units and must be stored in accordance with manufacturer instructions to maintain functionality. Each variant may include variations in features such as automatic or semi-automatic operation, advanced algorithms, and connectivity options, but all adhere to regulatory standards for automated external defibrillators.
Frequently asked questions
What is the primary purpose of the Powerheart AED G3 series, and how does it assist responders during emergencies?
The Powerheart AED G3 series are automated external defibrillators (non-wearable) designed to deliver life-saving electrical shocks to restore a normal heart rhythm in patients experiencing sudden cardiac arrest. These devices guide untrained responders through voice prompts and visual cues, ensuring proper cardiopulmonary resuscitation (CPR) and defibrillation techniques are followed during emergencies.
Are the Powerheart AED G3 models reusable or single-use, and how does this affect their maintenance?
The Powerheart AED G3 series includes models that are designed for both single-use and reusable applications, depending on the specific variant. Reusable models require periodic maintenance, calibration, and adherence to manufacturer guidelines to ensure continued functionality and safety, while single-use models are intended for one-time deployment before disposal.
What regulatory pathway does the Powerheart AED G3 series follow, and what does this mean for purchasers?
The Powerheart AED G3 series is classified as a Class III medical device under FDA regulations and has received 510(k) clearance (K102496) with a decision labeled as *Substantially Equivalent*. This means the device meets FDA standards for safety and effectiveness, and purchasers can rely on its compliance with regulatory requirements for automated external defibrillators. The clearance also indicates it falls under the Cardiovascular advisory committee for oversight.
How should the Powerheart AED G3 devices be stored to ensure they remain functional when needed?
The Powerheart AED G3 devices must be stored in accordance with the manufacturer’s instructions to maintain functionality. While specific storage conditions (e.g., temperature, humidity, or environmental protection) are not detailed here, proper storage typically involves keeping the device in a clean, dry location away from extreme temperatures and direct sunlight. Always refer to Cardiac Science Corporation’s guidelines for optimal preservation.
Are there different models within the Powerheart AED G3 series, and what distinguishes them from one another?
Yes, the Powerheart AED G3 series includes multiple models: Semi-Automatic, Automatic, Pro, and Plus. While all perform core functions like defibrillation and CPR guidance, distinctions likely include operational automation level (semi-automatic vs. fully automatic), advanced algorithms, connectivity features, or additional clinical enhancements. The exact differences are not specified here, but purchasers should consult the manufacturer’s documentation for model-specific capabilities.
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 | K102496 | Class III | Active |
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Manufacturer
- Manufacturer
- Cardiac Science Corporation
Sources (1)
- FDA 510(k) K102496 24 fields · synced Sep 18, 2026