HeartStart FRx Defibrillator, Model 861304
FDA 510(k)EUDAMEDClass III (US FDA 510(k))
Identifiers
- 510(k) Number
- K050004 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 HeartStart FRx Defibrillator, Model 861304, is an automated external defibrillator (AED) designed for use in sudden cardiac arrest emergencies. It delivers synchronized electrical shocks to restore normal heart rhythm in patients experiencing ventricular fibrillation or pulseless ventricular tachycardia, while providing voice-guided CPR instructions and an audible metronome for basic life support.
This lightweight, rugged, and battery-powered device is intended for minimally trained users in public access or workplace settings. Supplied with pre-installed SMART Pads II for adult and pediatric use, it requires no assembly beyond basic setup. The device adheres to FDA 510(k) clearance under Special Review (K050004) and complies with the Medical Device Directive (MDD). It is classified as a Class III device under 21 CFR 870.5310 and is intended for single-use or reusable applications depending on pad and battery replacement cycles.
Frequently asked questions
What types of emergencies is the Philips HeartStart FRx Defibrillator specifically designed to handle, and how does it guide users during an emergency?
The Philips HeartStart FRx Defibrillator is designed to handle sudden cardiac arrest emergencies, specifically for patients experiencing ventricular fibrillation or pulseless ventricular tachycardia. It delivers synchronized electrical shocks to restore a normal heart rhythm. During an emergency, the device provides voice-guided CPR instructions and an audible metronome to assist minimally trained users in performing basic life support, ensuring proper chest compression rate and depth.
Is the Philips HeartStart FRx Defibrillator intended for single-use or reusable applications, and what factors determine its reuse potential?
The Philips HeartStart FRx Defibrillator can be used for either single-use or reusable applications, depending on the replacement cycles of its pads and battery. The device itself is not explicitly limited to single-use, but its usability for reuse is contingent on the condition and proper maintenance of its components, particularly the pads and battery, which may need periodic replacement to ensure functionality and safety.
What kind of pads does the Philips HeartStart FRx Defibrillator come with, and do I need to assemble anything before use?
The Philips HeartStart FRx Defibrillator is supplied with pre-installed SMART Pads II, which are designed for both adult and pediatric use. No assembly is required beyond basic setup, making it user-friendly for minimally trained individuals in public access or workplace settings.
How portable and durable is the Philips HeartStart FRx Defibrillator, and what power source does it use?
The Philips HeartStart FRx Defibrillator is lightweight and rugged, making it highly portable for use in various settings. It is battery-powered, which enhances its mobility and ensures it can be used in locations without immediate access to electrical outlets.
What regulatory pathways has the Philips HeartStart FRx Defibrillator followed, and what does this mean for its use in clinical or public settings?
The Philips HeartStart FRx Defibrillator has received FDA 510(k) clearance under Special Review (K050004) and complies with the Medical Device Directive (MDD). This means the device has undergone rigorous evaluation to ensure its safety and effectiveness for use in sudden cardiac arrest emergencies, making it suitable for both clinical and public settings where minimally trained users may respond to cardiac events.
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: HeartStart FRx Automated external defibrillator - Philips, PDF HEARTSTART FRx DEFIBRILLATOR - Philips, Philips Heartstart FRx Defibrillator 861304
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Active |
| FDA 510(k) | United States | FDA_510K | K050004 | Class III | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems
Sources (2)
- FDA 510(k) K050004 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026