Defibrillators Alert! The FDA requires AED and defibrillator manufacturers to obtain premarket approval (PMA) for all models they sell. To obtain a PMA, the manufacturer must prove that its devices are safe, effective, and reliable. If a device, or its accessories, has not received a PMA it will no longer be available from the manufacturer after February 3, 2022. If your facility is still utilizing unapproved devices, now is the time to explore alternative options to ensure that the replacement AEDS and defibrillators are in place by the deadline.
Seattle Technology offers FDA Approved Defibs to fit a variety of needs and situations. Our units have the reliability and performance you can depend on in the most critical moments of care.
Leading the Marketplace in new and refurbished medical equipment, Seattle Technology provides meticulous craftsmanship, reasonable prices, and outstanding customer service. We offer the top three brand names in Defibrillators.
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FDA Compliant Defibrillators
The FDA requires AED and defibrillator manufacturers to obtain premarket approval (PMA) for all models they sell.
Why defibrillators need to be FDA Approved.
In 2015 the FDA published an order that requires defibrillator and AED manufacturers to file for premarket approval (PMA) for all defibrillators and AEDs and their accessories. Defibrillators and AEDs need to be FDA approved to ensure that these lifesaving pieces of equipment are safe and reliable. Problems with design and manufacturing issues may have contributed to patient harm.
Which defibrillators and AEDs are currently FDA approved?
There are many defibrillators and AEDs that are currently FDA-approved from top manufacturers like Cardiac Science, Defibtech, HeartSine, Philips, Physio-Control, and Zoll. Seattle Technology offers demo and refurbished units that are tested and calibrated back to the original manufacturer specifications by a team of highly skilled and trained biomedical engineers.
Defibrillators are used when individuals are experiencing cardiac arrest, cardiac arrhythmia’s, uneven heartbeats, or heartbeats that are too fast or slow. A defibrillator will restore a normal heart beat by sending an electric shock to the heart. Not only are they capable of sending electric shock, but some of these advanced devices can also monitor vital signs of a patient at the same time. Some of these parameters they can monitor include ECG, NIBP, IBP, CO2, Temperature and respiration.
Below is a list of availible FDA Compliant Defibrillators.
FDA Compliant AED’s
AED stands for automated external defibrillator. They are an easy-to-use medical device that allows trained and certified individuals to establish an effective heart rhythm. AEDs are used when an individual is experiencing sudden cardiac arrest. When used properly, this device will analyze the heart’s rhythm and deliver a shock if necessary. AEDs are found in most offices and public places and AED certification is open to everyone. If you’re looking for an AED certification class contact your local town’s police or fire department.
Below is a list of availible Defibrillators for EDUCATIONAL use. These Defibrillators can be used when FDA guidence is not required. This section also includes the FDA Approved Defibrillators.
Our selection of Emergency Care and Resuscitation systems help you respond to emergencies quickly and effectively wherever they occur. We offer a wide range of innovative, evidence-based emergency care and resuscitation solutions. We support you with services, accessories and programs to help give those you treat the best chance of returning to an active, normal life.
Early defibrillation is a critical component in treating cardiac arrest. We offer defibrillators to meet the needs of trained rescuers, first responders, and hospital professionals. Most of the defibrillators we offer feature a uniform operating system, so the need for training is minimized and ease of use is maximized.
The Zoll line of defibrillators include Real CPR Help® technology, which provides real-time feedback on the depth and rate of chest compressions. It’s all part of an extensive and integrated line of defibrillation solutions designed to advance the practice of resuscitation.