FDA 510(k) Clears Parker’s Indego® Exoskeleton for Clinical, Personal Use; State-of-the-Art Device Allows Individuals with Spinal Cord Injury to Stand and Walk

Submitted by kBLASTER Team on Apr 01, 2016

CLEVELAND (GLOBE NEWSWIRE) -- Parker Hannifin Corporation (NYSE: PH), the global leader in motion and control technologies, announced in March 2016 that the U.S. Food and Drug Administration (FDA) has given clearance to market and sell the Indego® exoskeleton for clinical and personal use in the United States. The company intends to commercially launch the device in the United States in the coming months. Indego is already commercially available in Europe, having received the CE Mark in November 2015.

“For individuals who sustain spinal cord injuries, this is a milestone that could have a meaningful impact on their lives,” said Tom Williams, chairman and CEO of Parker Hannifin. “In a relatively short amount of time, we have taken what was a prototype device and readied it for full commercial launch. We are excited about the future for this new growth opportunity.”

The FDA’s clearance came after the completion of the largest exoskeleton clinical trial conducted to date in the United States

“In sponsoring such a comprehensive and landmark study, Parker demonstrated the safety and performance of the Indego technology,” said Gary Ulicny, Ph.D., president and CEO of Shepherd Center, Parker’s lead clinical partner. “Over the course of more than 1,200 individual sessions, study participants were able to use Indego to safely walk on a variety of indoor and outdoor surfaces and settings with no serious adverse events.”

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