# K060934: Modification to Powerheart Ecd

- Pathway: 510(k) (Special)
- Applicant: Cardiac Science Corporation
- Decided: May 15, 2006 after 40 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K052316 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052316: Powerheart Ecd, Cardiac Science, Inc. (2006) Summary page 1.

## Recalls of this device
- Apr 28, 2010 · Not classified · Z-0589-2011: Some units may be non-operational during a rescue, due to a defective PCB interconnect on traces connected to the reed relay. This will result in an inability to analyze the patient's heart rhythm or 
- Oct 15, 2009 · Not classified · Z-1683-2010: The Operators Manual may not have adequate information to clearly explain some device behaviors. Pressing and holding down the Charge or Shock button on the Responder 2000 for more than 5 seconds caus

## Indications for use
The Powerheart ECD defibrillator system is intended to be used by personnel who have been trained in its operation. The Powerheart ECD is indicated for the termination of certain fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia. The semi-automatic advisory mode is for use in cardiac arrest in patients of at least 8 years of age. The patient must be unconscious, pulseless, and not breathing spontaneously before using the defibrillator to analyze the patient's ECG rhythm. The Powerheart ECD 3-lead and 5-lead ECG monitoring allows for identification or interpretation of cardiac rhythms or dysrhythmias and calculation of heart rate. The Powerheart ECD noninvasive pacing as a therapy is indicated for patients with symptomatic bradycardia or asystole. The Powerheart ECD pulse oximetry is intended for the continuous external monitoring of arterial oxygen saturation and pulse rate and is indicated for use in any patient who is at risk of developing hypoxemia.

Source page: https://510kreport.com/device/K060934
Methodology: https://510kreport.com/methodology