Defibtech Receives U.S. FDA Premarket Approval (PMA) for AEDs

Defibtech Receives U.S. FDA Premarket Approval (PMA) for AEDs

Guilford, CT
February 8, 2018

Defibtech is pleased to announce that we have received FDA Premarket Approval (PMA) for all Lifeline™ and ReviveR™ AED models offered for sale in the United States. A PMA is the most rigorous of FDA regulations for marketing a medical device in the United States. The approval means that Defibtech presented to the FDA sufficient scientific evidence that our AED devices are safe and effective for their intended uses.

Defibtech’s Lifeline and ReviveR brand of AEDs continue to meet or exceed Defibtech’s existing product performance specifications and our dedication to quality, reflected in this approval, extends to all areas of the company as we continue to strive to be the company that customers turn to for high quality and innovative offerings.

For media inquiries, contact:

Debra Ford
203-453-4507
dford@defibtech.com

About Defibtech

Defibtech, LLC, is a leader and innovator in the design and manufacture of automated external defibrillators (AEDs), mechanical chest compressors, and other lifesaving resuscitation products. By using advanced design and manufacturing techniques, Defibtech provides value-oriented, easy-to-use solutions with high quality and reliability. Defibtech devices include the LifelineTM and ReviverTM families of AEDs, Lifeline ARM mechanical chest compressors, and related accessories. With more than 300,000 defibrillators shipped worldwide in various language configurations, Defibtech has drawn accolades and won numerous awards for innovative product design, growth, quality, and services. Defibtech’s products are sold exclusively through their network of distribution partners in the United States and in over 50 countries around the world. Headquartered in Guilford, Conn., all Defibtech products are designed and manufactured in the United States in state-of-the-art ISO compliant facilities. For more information about Defibtech and its products, visit www.defibtech.com.

About Nihon Kohden Corporation

Founded in Japan in 1951, Nihon Kohden is the leading manufacturer, developer and distributor of medical electronic equipment, with subsidiaries in the U.S., Europe and Asia. The company’s products are now used in more than 120 countries, and it is the largest supplier of electroencephalography products worldwide. A pioneer in transformational healthcare technology, Nihon Kohden has envisioned, designed and produced revolutionary devices, such as pulse oximeters, arrhythmia analysis, low-invasive blood volume monitoring and wireless patient monitoring. For more information, visit www.nihonkohden.com.