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Molekule Launches New Commercial Product, Air Pro RX, with FDA 510(k) Class II Medical Device Clearance
April 29, 2020
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.”
See Full Press Release: Molekule Launches New Commercial Product, Air Pro RX, with FDA 510(k) Class II Medical Device Clearance
Written by: Molekule
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