Walking Approval

The U.S. Food and Drug Administration (FDA) approved marketing of the Rewalk. The exoskeleton, which assists with walking, is the first robotic device of its kind to gain FDA approval.
Reprinted from PN/Paraplegia News September 2014

The U.S. Food and Drug Administration (FDA) approved marketing of the first exoskeleton for people with lower body paralysis because of spinal-cord injury (SCI): ReWalk.

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ReWalk is a robotic, motorized device worn over the legs and part of the upper body that helps those with SCI sit, stand and walk. The user wears the device which includes a remote worn on the wrist to control the movement the suit provides to hips, knees and ankles.

The remote signals the computer component, worn in a backpack, and then moves the suit, which in turn moves the user who is strapped in. The wearer uses a set of crutches for stability when moving in the exoskeleton.

“Innovative devices such as ReWalk go a long way towards helping individuals with spinal-cord injuries gain some mobility,” says Christy Foreman, director of the Office of Device Evaluation, at the FDA’s Center for Devices and Radiological Health. “Along with physical therapy, training and assistance from a caregiver, these individuals may be able to use these devices to walk again in their homes and in their communities.”

The device has been used for rehabilitation purposes, but now with FDA approval, ReWalk is on the market for personal use. Users and caregivers must be trained by the manufacturer to learn how to safely and properly use the product.

Users should also have experience standing in other assistive devices prior to using ReWalk. People with a history of severe neurological injuries other than SCI, unhealed limb or pelvic fractures, severe spasticity, significant contractures or unstable spine should not use the device.

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