X-PLO₂R, a portable oxygen concentrator developed by Belluscura and its research partner Separation Design Group, has been cleared for commercialization in the U.S.
The Food and Drug Administration (FDA) cleared the company’s premarket notification, or 510(k), and granted marketing authorization to the new device. Premarket notification is a formal document that medical device manufacturers must submit to the FDA at least 90 days in advance if they intend to market their product.
This document also enables the FDA to determine whether a medical device is equivalent to one already on the market and to give it the proper classification. This is required both for new devices and when reintroducing an existing device with significant changes that may affect its safety or effectiveness.
The X-PLO₂R portable oxygen concentrator is designed to improve the quality of life of people with chronic obstructive pulmonary disease (COPD) and other respiratory disorders by providing a lightweight and more convenient alternative to other standard oxygen delivery systems.
Weighing under 3.25 lbs (1.5 kg), the X-PLO₂R fits into a backpack and is based on a patented technology that allows it to deliver up to 95% pure oxygen to patients. This should enable users to more easily engage in a wider range of activities by replacing large, metal oxygen tanks and other heavier portable devices. The new device is expected to become commercially available soon.
“Belluscura researched the portable oxygen market and concluded that new technology could improve the quality and efficiency of oxygen concentrators while also reducing the cost to the patient and caregiver,” Robert Rauker, CEO of Belluscura, said in a press release.
The X-PLO₂R is the first product developed by the company to gain marketing authorization.
Rauker noted that Belluscura has long focused on developing innovative products based on oxygen enrichment technologies with the licensing, acquisition, and joint invention of “18 patents and applications in the field of concentrated oxygen generation.”
X-PLO₂R is expected to soon join other portable oxygen concentrators currently in the U.S. market, including GCE Healthcare’s Zen-O lite and ResMed’s Mobi, each weighing 5.5 lbs (2.49 kg).
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