An orthopedic rehabilitation device called the Med4 Elite that applies alternating heat and cooling to a wound area (113 degrees Fahrenheit to 38 degrees Fahrenheit in less than one minute) has received 510(k) clearance from the FDA.
FDA Clears Hot and Cold Wound Treatment Machine
1 min read Premium comments
Secondary
The Med4 Elite is described by its manufacturer, Game Ready of Concord, California, as being a “powerful multi-modality rehabilitation tool.” It is controlled by a touchscreen computer interface and delivers iceless cold therapy, heat therapy, rapid contrast (alternating heat and cold) therapy and intermittent pneumatic compression therapy.
Game Ready was founded in 1997 and company officials say that over a million people worldwide have experienced “a better, faster recovery by using their company’s products.”
“The future of orthopedic recovery has arrived,” said Craig Grabell, CEO and president. “With the launch of the Med4 Elite we are changing the post-operative and post-injury landscape. The Med4 Elite features Game Ready’s proprietary Rapid Changeover Technology™ for contrast therapy, which allows for a groundbreaking switch from heat at 113 degrees Fahrenheit to cold at 38 degrees Fahrenheit in less than one 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.”
Current methods of rapid contrast therapy require multiple cumbersome devices and a large amount of space, according to Grabell. He adds that the Med4 Elite provides a greatly improved application of therapy due to its compact but powerful footprint. A wide portfolio of patented, anatomically designed Game Ready Wraps delivers the Med4 Elite therapy for an effective and comfortable recovery experience.
Game Ready received a CE Mark for the Med4 Elite in August 2017 and began international sales, with the first systems shipped to Spain, France and the United Kingdom.
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.