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ReWalk exoskeleton gets FDA approval for home use

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June 26, 2014

The ReWalk motorized exoskeleton, which has been available in the UK since 2012, has now b...

The ReWalk motorized exoskeleton, which has been available in the UK since 2012, has now been cleared by the FDA for home use in the US

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Following multiple clinical studies, the Food and Drug Administration (FDA) has cleared the way for the ReWalk to be sold for personal use in the US. This makes the ReWalk the first motorized exoskeleton designed for people with lower body paralysis due to spinal cord injury to be cleared for personal use in the US.

ReWalk consists of a wearable brace support worn outside clothing, a computer-based control system and motion sensors to enable paraplegics to sit, stand, walk and even climb stairs with a little motorized help. Until now, the ReWalk technology has only been available in the US at rehabilitation clinics in the form of the ReWalk Rehabilitation system. This version is designed specifically for use in a clinical rehabilitation environment and as such can be adapted to fit users of different sizes and weights.

The ReWalk motorized exoskeleton has been cleared by the FDA for home use in the US

The ReWalk Personal System, on the other hand, is customized to suit a specific user and is designed for daily use in a range of environments, including outdoors and on a variety of surfaces and terrains. It was first cleared for personal use in the UK in 2012 and has been available there and throughout Europe since that time. Now those in the US have the chance to take home their own ReWalk with the FDA issuing a marketing clearance for the device.

"This revolutionary product will have an immediate, life-changing impact on individuals with spinal cord injuries," said Larry Jasinski, CEO of ReWalk Robotics. "For the first time individuals with paraplegia will be able to take home this exoskeleton technology, use it every day and maximize on the physiological and psychological benefits we have observed in clinical trials."

Potential customers will need to become certified in using the ReWalk system by completing a training program and undergoing a medical examination.

Source: ReWalk

About the Author
Darren Quick Darren's love of technology started in primary school with a Nintendo Game & Watch Donkey Kong (still functioning) and a Commodore VIC 20 computer (not still functioning). In high school he upgraded to a 286 PC, and he's been following Moore's law ever since. This love of technology continued through a number of university courses and crappy jobs until 2008, when his interests found a home at Gizmag.   All articles by Darren Quick
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3 Comments

This is very cool.. should help with issues with circulation and atrophy common to those with paralysis injuries.

hdm
27th June, 2014 @ 06:11 am PDT

Yes an amazing invention - the author forgot to mention that this was invented in Israel ! Yes another example of the Start-up Nation's success !

Shai Spetgang
28th June, 2014 @ 12:11 pm PDT

Upgrade the mecanics and extend the potential customer base to include obese people and this thingie sure will have a bright future.

Conny Söre
30th June, 2014 @ 12:36 pm PDT
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