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Powerheart AED G3 (Model 9390E), Powerheart AED G3 Automatic (Model 9390A)

FDA 510(k)

Class III (US FDA 510(k))

510(k) K052161

by Cardiac Science Corporation

Identifiers

510(k) Number
K052161 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 (Models 9390E and 9390A) is an Automated External Defibrillator (Non-Wearable), designed to deliver life-saving electrical shocks to restore normal heart rhythm in victims of sudden cardiac arrest. These devices provide voice prompts and visual guidance to assist untrained responders in performing cardiopulmonary resuscitation (CPR) and delivering defibrillation therapy when indicated.

The Powerheart AED G3 is intended for use in public and clinical settings, including homes, workplaces, and emergency response environments. Supplied as a reusable device, it requires periodic maintenance and calibration. The models are classified as Class III medical devices under FDA regulations, with clearance via a Special 510(k) pathway. Storage and handling follow manufacturer guidelines to ensure proper functionality and sterility of reusable components.

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: PDF Cardiac Science Powerheart G3 Plus AED Manual - Heartsmart, Cardiac Science Powerheart AED G3 Plus Automatic AED Defibrillator ..., Cardiac Science POWERHEART AED 9390E Operator's And Service Manual, Powerheart® Aed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cardiac Science Corporation
FDA Applicant
Cardiac Science, Inc.

Sources (1)

  • FDA 510(k) K052161 24 fields · synced Sep 18, 2026