← Back to catalogue

Powerheart AECD

FDA 510(k)

Class III (US FDA 510(k))

510(k) K993533

by Cardiac Science Corporation

Identifiers

510(k) Number
K993533 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
ST FDA 510(k)

The Powerheart AECD 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 is a portable, non-invasive device intended for use by trained or untrained responders in emergency situations where cardiac arrest occurs.

The Powerheart AECD is supplied as a reusable medical device, intended for use in clinical and pre-hospital settings. It requires FDA clearance under 510(k) and is classified as a Class III device under regulation number 870.5310. The device is not specified as MRI-safe, and its operational readiness is verified through self-testing technology. Storage and handling follow standard medical device protocols to ensure functionality and sterility.

Frequently asked questions

Is the Powerheart AECD suitable for use by untrained responders in emergency cardiac arrest situations, and how does it guide them through the process?

Yes, the Powerheart AECD is explicitly designed for use by both trained and untrained responders in emergency situations where sudden cardiac arrest occurs. It is a non-wearable automated external defibrillator (AED) that provides voice prompts and step-by-step guidance to assist users through the resuscitation process, even if they lack prior medical training.

How is the Powerheart AECD supplied, and is it intended for single-use or reusable applications?

The Powerheart AECD is supplied as a reusable medical device, intended for use in both clinical and pre-hospital settings. Unlike disposable pads or accessories, the core defibrillator unit itself is designed for repeated use, though consumable components like electrode pads may require periodic replacement according to manufacturer guidelines.

Does the Powerheart AECD include built-in functionality to verify its operational readiness before use, and how does this benefit responders?

Yes, the Powerheart AECD incorporates self-testing technology to verify its operational readiness. This feature ensures that the device is functional and ready to deliver a shock when needed, reducing the risk of failure during a critical moment and providing responders with confidence in its reliability before use.

What storage and handling protocols should be followed to maintain the Powerheart AECD’s functionality and sterility?

The Powerheart AECD follows standard medical device protocols for storage and handling to ensure functionality and sterility. This includes proper environmental conditions (e.g., temperature, humidity), protection from physical damage, and adherence to manufacturer guidelines for maintenance and calibration. Since it is reusable, regular cleaning and inspection are also recommended to uphold performance and hygiene.

What regulatory pathway was followed for the FDA clearance of the Powerheart AECD, and what classification does it hold?

The Powerheart AECD received FDA clearance through a 510(k) premarket notification process, specifically classified as a Class III device under regulation number 870.5310. This pathway was used to demonstrate substantial equivalence to a predicate device, and the clearance was granted under a special type of decision (ST) by the FDA’s Cardiovascular (CV) advisory committee. The device is not MRI-safe, as explicitly noted in its documentation.

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 AED | Cardio Care USA, Shop Cardiac Science Powerheart AEDs | AED.com, Cardiac Science Powerheart AED G3 Instructions For Use Manual

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cardiac Science Corporation
FDA Applicant
Cardiac Science, Inc.

Sources (1)

  • FDA 510(k) K993533 24 fields · synced Sep 18, 2026