Molekule Launches New Commercial Product, Air Pro RX, with FDA 510(k) Class II Medical Device Clearance
Air Pro RX is intended for medical purposes to destroy airborne viruses and bacteria
SAN FRANCISCO, April 23, 2020 /PRNewswire/ -- Molekule, the leader in reinventing air purification, today announced that the U.S. Food and Drug Administration (FDA) cleared the 510(k) premarket notification for its new medical-grade air purifier, Air Pro RX, classifying it as a 510(k) Class II Medical Device. The Molekule Air Pro RX air purifier is intended for medical purposes to destroy bacteria and viruses in the air and is well-suited for use in operating rooms, emergency department waiting rooms, isolation units, and any critical or high-traffic area in healthcare facilities to provide additional frontline protection. The FDA clearance comes in the midst of the COVID-19 crisis, in which the potential of airborne viruses are becoming of increasing concern.
Air Pro RX uses Molekule's patented Photo Electrochemical Oxidation (PECO) technology, and has demonstrated greater than 5-log, or 99.999% reduction, of RNA virus MS2 at 24 hours as a proxy virus for SARS-CoV-2. In addition, Air Pro RX meets all applicable performance criteria recommended by the FDA guidelines for use in reducing the spread of SARS-CoV-2 in healthcare settings. Because of PECO technology's ability to capture and destroy bioaerosols, the device is intended to keep patients and healthcare staff better protected in high-risk areas.
Air Pro RX, along with Molekule Air units, are currently in use at Mercyhealth hospitals across Wisconsin and Illinois.
"It's critical now more than ever to consider new air purification technology and how it moves medical facility air quality standards forward and protects their patients," said Jaya Rao, Co-CEO and Co-Founder of Molekule. "With the launch of Air Pro RX and clearance from the FDA, this product allows us to reach those at their most vulnerable. We are incredibly grateful to the FDA for their thorough review process and speed in the midst of the COVID-19 crisis. This FDA clearance enables us to begin to deploy our devices into medical settings immediately."
Air Pro RX does not require any installation and begins cleaning the air immediately after start-up. It comes with a Pre-Filter, which is optimized for large particle capture, and a PECO-Filter, which is optimized to destroy bacteria, viruses, and other airborne contaminants. Air Pro RX is also easily cleaned and compatible with standard wipe-down disinfection protocols used in hospital facilities. Molekule also offers a non-medical grade air purifier, Air Pro, suitable for enterprise businesses and large commercial areas including office spaces, grocery stores, schools, sporting facilities, gyms, food processing and manufacturing sites, indoor commercial farming & agriculture, animal-care facilities, and more, providing clean, purified air for large-scale, highly trafficked commercial spaces.
If you are a medical or healthcare facility interested in Molekule, more information can be found here.
About Molekule
Molekule is on a mission to provide clean indoor air to everyone, everywhere. Based on more than 20 years of research and development, our patented photo electrochemical oxidation (PECO) technology destroys a whole range of tiny pollutants, including VOCs, mold, bacteria, viruses and allergens. Using science to revolutionize air purification in ways that the industry hasn't seen, PECO sits at the crux of Molekule's air purification technology and has been rigorously validated by third-party laboratories and continual internal testing. We believe air pollution is one of the greatest challenges of our time, as it has been attributed to seven million premature deaths a year, according to the World Health Organization. This is why we are dedicated to the fight for clean air and are actively working with scientists, doctors, sufferers, and policy-makers to offer a fundamentally different approach to air purification. For more information, visit https://molekule.com
Molekule Media Contact
Stephanie Borman
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SOURCE Molekule
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