ReWalk Personal Exoskeleton Receives FDA De Novo Clearance
The FDA has cleared ReWalk Robotics’ ReWalk Personal System, the first motorized device intended to act as an exoskeleton for people with lower-body paralysis due to a spinal cord injury. The clearance, announced Thursday, was issued via the agency’s de novo process.
The motorized device features a fitted metal brace worn over the legs and part of the upper body that helps a patient sit, stand and walk with assistance from a trained companion. Motors allow movement at the hips, knees and ankles.
According to the Marlborough, Mass., devicemaker, the individual commands ReWalk to stand, sit or walk using a wireless remote worn on the wrist. Crutches provide the user with additional stability, and a tilt sensor helps to prevent falls. A backpack contains the computer and power unit, ReWalk Robotics explains.
The ReWalk Personal system is available to users once they successfully complete ReWalk training at a rehab facility or VA Hospital and pass a medical examination, company spokeswoman Jennifer Wlach told Device Daily Bulletin. The device is designed for everyday use at home and in the community.
The de novo process allows for marketing clearance of devices that pose a low risk to health. No 510(k) submission is required, Wlach said. — Kellen Owings
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