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Powerheart ECD Modification

FDA 510(k)

Class III (US FDA 510(k))

510(k) K060934

by Cardiac Science Corporation

Identifiers

510(k) Number
K060934 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 ECD Modification is an Automated External Defibrillator (Non-Wearable), designed to deliver electrical shocks to restore normal heart rhythm in patients experiencing sudden cardiac arrest. This device is intended for use by trained responders, including healthcare professionals and laypersons, to treat ventricular fibrillation or pulseless ventricular tachycardia in out-of-hospital and pre-hospital settings.

This modification is supplied as a reusable medical device, intended for use in emergency response scenarios. It is not classified as MRI-safe and requires proper storage in a clean, dry environment to maintain functionality. The device holds FDA 510(k) clearance (K060934) and is regulated under 21 CFR 870.5310, adhering to strict cardiovascular device standards. No sterility claims are made, and its use is governed by applicable clinical guidelines and regulatory compliance.

Frequently asked questions

Is this device intended for single-use or can it be reused in multiple emergency situations?

This device is explicitly described as a reusable medical device. It is designed for use in multiple emergency response scenarios, provided it is properly maintained and stored in a clean, dry environment to ensure functionality. Unlike single-use devices, it does not require disposal after each use, but it must still adhere to manufacturer guidelines for cleaning and servicing.

What storage conditions are required to maintain the device’s functionality, and does it have any special handling instructions?

The device must be stored in a clean, dry environment to preserve its performance. There are no claims of sterility, so it is not intended for sterile procedures. Additionally, it is not MRI-safe, meaning it should not be placed near MRI machines or environments where magnetic fields are present. Proper storage also includes following manufacturer guidelines for maintenance and servicing to ensure reliability in emergency scenarios.

What regulatory pathway was followed for this modification, and what classification does it hold?

This modification to the Powerheart ECD received FDA 510(k) clearance under the classification of Class III (as indicated by the OpenFDA data). The submission was reviewed by the Cardiovascular (CV) Advisory Committee and was determined to be substantially equivalent to a predicate device. It is regulated under 21 CFR 870.5310, which governs cardiovascular devices, ensuring compliance with strict safety and performance standards.

Can this device be used in both in-hospital and out-of-hospital settings, or is it limited to specific environments?

The device is intended for use in out-of-hospital and pre-hospital settings, meaning it is designed for emergency responders, including healthcare professionals and trained laypersons, to treat sudden cardiac arrest outside of clinical facilities. While it can be used in pre-hospital scenarios, it is not explicitly described as suitable for in-hospital use, where other defibrillators may be preferred.

How is this modification different from the original Powerheart ECD, and what specific improvements or changes does it include?

The provided data does not specify the exact nature of the modifications, but the FDA 510(k) clearance (K060934) indicates it was reviewed as a substantially equivalent update to the original device. This typically means the modification maintains the same intended purpose—delivering electrical shocks for ventricular fibrillation or pulseless ventricular tachycardia—but may include design, performance, or safety enhancements. For precise details on changes, refer to the manufacturer’s documentation or the FDA submission records.

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) K060934 24 fields · synced Sep 18, 2026