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Cardiac Science Corporation

Last updated May 30, 2026

What Cardiac Science Corporation makes

Cardiac Science Corporation manufactures non-rechargeable and rechargeable automated and semi-automated external defibrillators (AEDs) for public use, including models with integrated CPR feedback. Their portfolio includes single-use and reusable adult and pediatric defibrillation electrodes, primary and secondary batteries, and multifunction cardiac treatment electrodes. The company also provides external defibrillation application software and AED management systems for monitoring and maintenance.

The company’s devices are classified as Class II and Class III under FDA regulations, with submissions recorded in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. Their products are listed in the US, where the manufacturer is based.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Cardiac Science Corporation manufacture?

Cardiac Science Corporation specializes in external defibrillation devices primarily designed for public use. Their portfolio includes non-rechargeable and rechargeable automated external defibrillators (AEDs), both fully automated and semi-automated models. This also covers accessories like single-use and reusable adult and pediatric defibrillation electrodes, primary and secondary batteries, and multifunction cardiac treatment electrodes. Some devices also include integrated CPR feedback technology and software for defibrillation applications and AED management.

Where is Cardiac Science Corporation based, and where are their devices listed?

Cardiac Science Corporation is based in the United States. Their devices are listed in the FDA’s regulatory databases, specifically under the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. These registries track the authorization status and compliance of their products in the US market.

How are Cardiac Science Corporation’s devices classified under FDA regulations?

Cardiac Science Corporation’s devices fall under two FDA classification categories: Class II and Class III. Class II devices generally pose moderate risk and require special controls to ensure safety and effectiveness, while Class III devices are higher risk and typically require premarket approval due to insufficient data showing safety and performance. The classification depends on the specific device type, such as defibrillators or electrodes, and their intended use.

What does it mean for Cardiac Science Corporation’s devices to be listed in the FDA’s 510(k) and UDI databases?

Listing in the FDA’s 510(k) database indicates that the manufacturer has submitted a premarket notification to demonstrate that their device is substantially equivalent to a legally marketed predicate device. This process helps the FDA determine whether the device can be marketed in the US without further regulatory action. The Unique Device Identifier (UDI) database ensures each device has a unique product code for tracking, improving patient safety, and streamlining regulatory oversight by providing clear identification of the device’s specifications and authorization status.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: cardiacscience.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1.262.953.3500
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 190713797

Catalogue (76)

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Device	Model / Reference	Registries	Class	Status
Responder AED Battery	2019437-301	FDA UDI	Class III	Active
FirstSave AED Battery	9143-301	FDA UDI	Class III	Active
Powerheart®Pediatric Pads	9730-002	FDA UDI	Class III	Active
Powerheart® Polarized Adult Defibrillation Pads	9660-001	FDA UDI	Class III	Active
Powerheart® G5 Automatic AED	G5A-01A	FDA UDI	Class III	Active
Powerheart Aecd	K970741	FDA 510(k)	Class III	Active
Atria 3100, Atria 6100	K060167	FDA 510(k)	Class II	Active
Powerheart Aed G3 Semi-Automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro, Powerheart Aed G3 Plus	K102496	FDA 510(k)	Class III	Active
Multifunctional Electrode Models 9640, 9650	K022210	FDA 510(k)	Class III	Active
Powerheart G5 Aed	K122758	FDA 510(k)	Class III	Active
Powerheart Aecd	K993533	FDA 510(k)	Class III	Active
Powerheart Aed G3 (model 9390e), Powerheart Aed G3 Automatic (model 9390a)	K052161	FDA 510(k)	Class III	Active
Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model 9200/9210	K022929	FDA 510(k)	Class III	Active
Powerheart G5 AED	K143714	FDA 510(k)	Class III	Active
Powerheart Aed G3, Model 9390e, Powerheart Aed G3 Automatic, Model 9390a	K091943	FDA 510(k)	Class III	Active
Powerheart Aed G3 Pro	K040637	FDA 510(k)	Class III	Active
Mysense Heart	K113176	FDA 510(k)	Class II	Active
9131 Defibrillation Electrodes	K082090	FDA 510(k)	Class III	Active
Q-Stress And Heartstride, Models Qstress/Q40 And H4/H4s	K082173	FDA 510(k)	Class II	Active
Modification To Powerheart Ecd	K060934	FDA 510(k)	Class III	Active
Powerheart Ecd	K052316	FDA 510(k)	Class III	Active
Powerheart Aed G3, Model 9300	K031987	FDA 510(k)	Class III	Active
Powerheart Cardiac Rhythm Module	K012197	FDA 510(k)	Class III	Active
Aecd Arrhythmia Detection Software	K982710	FDA 510(k)	Class III	Active
Powerheart Aed G3a	K040438	FDA 510(k)	Class III	Active
Carecenter Md	K093211	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (47)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Cardiac Science Corporation has 47 recall records initiated between May 4, 2004, and June 4, 2019, all marked as terminated. The recalls involve external defibrillators and stress/rehab treadmills, with reasons including extended charge times in capacitors, manufacturing errors in adapter cables, insufficient documentation for printed circuit boards, incorrect fuses in batteries, inadequate electrical safety testing, self-test errors causing service requirements, electronic component specification deviations, unclear operator manual instructions, potential circuit board failures, relay switch malfunctions, and discontinuation of accessory sales for specific models.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jun 4, 2019	Z-1938-2019	—	terminated	Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.
Jan 13, 2012	Z-1057-2012	—	terminated	The affected Automated External Defibrillators (AEDs) contains a circuit board manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy.
Jun 30, 2011	Z-3265-2011	—	terminated	Cardiac Science Corporation (CSC) has identified two errors, 0x48 and 0x99, that have repeatedly occurred during a device self-test in the G3 installed base over the last 6 years. These self test errors cause the device to enter into a service required state. CSC remind owners/operators of the Powerheart AED devices to verify the "Rescue Readiness" of their equipment and follow maintenance pro
Jun 29, 2011	Z-2917-2011	—	terminated	Cardiac Science Corporation (CSC) intent to end service support and discontinue accessory sales of Powerheart G2 Automated External Defibrillators. Customers are recommended to choose a replacement AED prior to the current AED displaying any "Service Required" self test messages.
Apr 28, 2010	Z-0589-2011	—	terminated	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 deliver therapy during a rescue.
Feb 3, 2010	Z-1247-2010	—	terminated	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
Feb 3, 2010	Z-1245-2010	—	terminated	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
Feb 3, 2010	Z-1244-2010	—	terminated	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
Feb 3, 2010	Z-1243-2010	—	terminated	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
Feb 3, 2010	Z-1249-2010	—	terminated	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
Feb 3, 2010	Z-1246-2010	—	terminated	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
Feb 3, 2010	Z-1248-2010	—	terminated	A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
Dec 18, 2009	Z-1810-2010	—	terminated	The K302 relay switch of the G3 series AED product line may experience an early failure. If the K302 contacts are open at the time of rescue, there is a possible delay in therapy or failure to deliver therapy.
Nov 13, 2009	Z-0776-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0770-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0769-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0772-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0767-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0773-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0765-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0777-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0775-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0766-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0778-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0774-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0768-2010	—	terminated	Potential for devices not to deliver therapy
Nov 13, 2009	Z-0771-2010	—	terminated	Potential for devices not to deliver therapy
Oct 15, 2009	Z-1683-2010	—	terminated	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 causes a "Button Stuck" error. With the "Button Stuck" error, the device will automatically exit Manual mode and enter Monitor mode. The user cannot apply therapy while the device is in Monitor mode.
Oct 12, 2009	Z-1424-2010	—	terminated	Certain models of Powerheart G3 AEDs may not have received adequate electrical safety testing prior to being shipped from the factory. Affected models are: Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198 and 2023440. The affected devices were manufactured between October 29, 2003 and February 10, 2009.
Mar 30, 2009	Z-1757-2010	—	terminated	28 stress and rehab treadmills manufactured between September 2006 and January 2009 may not have received adequate electrical safety testing prior to being shipped from the factory. If these components break down in the field, a patient or operator could be exposed to excess touch currents on the surface of the product. Because safety testing may not have allowed for complete evaluation of the el
Oct 13, 2008	Z-0921-2009	—	terminated	Potential for AED to not deliver defibrillation therapy.
Oct 13, 2008	Z-0917-2009	—	terminated	Potential for AED to not deliver defibrillation therapy.
Oct 13, 2008	Z-0918-2009	—	terminated	Potential for AED to not deliver defibrillation therapy.
Oct 13, 2008	Z-0920-2009	—	terminated	Potential for AED to not deliver defibrillation therapy.
Oct 13, 2008	Z-0916-2009	—	terminated	Potential for AED to not deliver defibrillation therapy.
Oct 13, 2008	Z-0919-2009	—	terminated	Potential for AED to not deliver defibrillation therapy.
Oct 13, 2008	Z-0922-2009	—	terminated	Potential for AED to not deliver defibrillation therapy.
Jan 23, 2008	Z-1714-2008	—	terminated	Instructions For Use is not clear about how the AED voice and text prompts will differ when the adapter is used.
Jan 23, 2008	Z-1616-2008	—	terminated	Adaptor Cable Incorrectly Manufactured: The red and white connector ends of the adapter are switched. Therefore, the cable will not connect to the electrodes as indicated in the instructions.
Jan 27, 2006	Z-0623-06	—	terminated	Some Powerheart AED Model 9300A may contain a suspect electronic component and there is a remote likelihood that the function of this device may be interrupted during the charge.
Nov 12, 2004	Z-0400-05	—	terminated	AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not functionn properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is presrent it will delay the first defibrillation shock in the 3 shock sequence.
Nov 12, 2004	Z-0399-05	—	terminated	AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not functionn properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is presrent it will delay the first defibrillation shock in the 3 shock sequence.
Nov 12, 2004	Z-0398-05	—	terminated	AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not functionn properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is presrent it will delay the first defibrillation shock in the 3 shock sequence.
May 24, 2004	Z-1034-04	—	terminated	Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be turn on.
May 24, 2004	Z-1033-04	—	terminated	Some of the high voltage capacitors in the recalled external defibrillators have had extended charge times resulting in self-test failures following which the defibrillator cannot be used/cannot be turn on.
May 4, 2004	Z-0990-04	—	terminated	Some of the recalled defibrillator batteries contain an incorrect fuse which could open resulting in a defibrillator which will not work.
May 4, 2004	Z-0991-04	—	terminated	Some of the recalled defibrillator batteries contain an incorrect fuse which could open resulting in a defibrillator which will not work.