The FDA, in order to assess the safety and effectiveness of ReWalk, has reviewed testing done to evaluate ReWalk’s durability, its hardware, software and battery systems, and other safety systems that help minimize risk of injury should the device lose balance or power.

Clinical data based on 30 study participants has also been reviewed by the FDA. In addition, observational data from 16 patients were also provided to support use of the device on various walking surfaces.

Argo Medical Technologies has designed the ReWalk device for people with paraplegia due to spinal cord injuries at levels T7 (seventh thoracic vertebra) to L5 (fifth lumbar vertebra) when accompanied by a specially trained caregiver.

The motorized device is also for people with spinal cord injuries at levels T4 (fourth thoracic vertebra) to T6 (sixth thoracic vertebra) where the device is limited to use in rehabilitation institutions.

It is worn over the legs and part of the upper body that helps an individual sit, stand, and walk with assistance from a trained companion.

The motorized device features a fitted, metal brace that supports the legs and part of the upper body; motors that supply movement at the hips, knees, and ankles; a tilt sensor; and a backpack that contains the computer and power supply.

According to the company, crutches provide the user with additional stability when walking, standing, and rising up from a chair. Using a wireless remote control worn on the wrist, the user commands ReWalk to stand up, sit down or walk.

The FDA is requiring the company to complete a post-market clinical study, which will have a registry to collect data on adverse events related to the use of the ReWalk device and prospectively and systematically assess the adequacy of its training program.