FDA cleared the Med4 Elite, an orthopedic rehabilitation device, from Game Ready.Cool Systems Inc.
Physical therapists have a new tool to help them treat patients at various stages of rehabilitation. FDA cleared the Med4 Elite, an orthopedic rehabilitation device, from Game Ready, which is part of Concord, CA-based CoolSystems Inc.
The new technology comes with four options in one device: iceless cold therapy, heat therapy, rapid contrast therapy (which alternates heat and cold), and intermittent pneumatic compression therapy. The flexibility of the different treatment options will allow physicians and physical therapists to treat a wide range of injuries in various stages of rehabilitation to help patients recover more quickly and comfortably, the company said.
“The future of orthopedic recovery has arrived,” said Craig Grabell, the company's president and CEO. “With the launch of the Med4 Elite, we are changing the postoperative and post-injury landscape. This is a landmark moment for Game Ready and our customers.”
The new device features the company’s rapid changeover technology, a feature specifically designed for contrast therapy. This new feature allows for the device to switch from heat at 113 degrees Fahrenheit, to a cold therapy at 38 degrees Fahrenheit in less than 60 seconds. Grabell said the device will not only be transformative for athletes looking to recover from an injury but can be used to treat virtually any patient in search of an orthopedic therapy tool that offers a variety of therapies on one simple platform.
Current rapid contrast therapies require multiple devices that can be cumbersome and uncomfortable, requiring large amounts of space to operate. Game Ready’s new technology is compact and anatomically designed to provide a more comfortable therapeutic experience that offers more efficient and effective treatment options, according to the company.
In addition to FDA clearance, the device can be sold in European countries under a CE mark. Game Ready also plans to add additional therapies to the device and expand its technologies to improve rehabilitation for U.S. athletes and patients.
“We are excited to build on the success of our GRPro 2.1 and add additional therapies that will help providers get patients back to being their best,” Grabell said. “Game Ready is not just for world-class athletes. Elite technology for everyone is what Game Ready is all about.”