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Game Ready receives FDA 510(k) clearance for orthopedic rehabilitation device
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Game Ready announced it has received FDA 510(k) clearance for Med4 Elite, an orthopedic rehabilitation device.
According to a company press release, the device is controlled by a touchscreen computer interface. The system delivers iceless cold therapy, heat therapy and alternating heat and cold therapy, as well as pneumatic compression therapy. Med4 Elite offers health care providers with treatment options for various patients, procedures, injuries and rehabilitation stages.
“The future of orthopedic recovery has arrived,” Craig Grabell, chief executive officer and president of the company, said in the release. “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 Med4 Elite features Game Ready’s proprietary rapid changeover technology for contrast therapy, which allows for a groundbreaking switch from heat at 113°F to cold at 38°F in less than 1 minute. We are excited to build on the success of our GRPro 2.1, and add additional therapies that will help providers get all their patients back to being their best. Game Ready is not just for world-class athletes. Elite technology for everyone is what Game Ready is all about.”
In August 2017, Game ready received CE mark approval for the Med4 Elite and began sales in Spain, France and the United Kingdom.
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