ReWalk Robotics has announced that the ReWalk Personal System has received FDA clearance for use at home and in the community. It is the first motorized device intended to act as an exoskeleton in individuals 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, and for those with injuries at levels T4 (fourth thoracic vertebra) to T6 (sixth thoracic vertebra), where the device is limited to use in rehabilitation institutions. The device is not intended for sports or climbing stairs.

The ReWalk Personal System consists of a metal brace supporting 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. For additional stability while walking, standing, and rising up from a chair, crutches are utilized. A wireless remote control worn on the wrist allows the user to command ReWalk to stand up, sit down or walk. Patients should be able to stand using an assistive standing device prior to ReWalk use training and their hands and shoulders should be able to support crutches or a walker. Patients and their caregivers are required to undergo training developed by the manufacturer to learn and demonstrate proper use of the device.

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The FDA clearance was based on a review of clinical data from 30 study participants that evaluated the participants’ ability to walk various distances, amount of time needed to walk various distances, performance on various walking surfaces and slight slopes, and performance walking in areas where jostling might occur. Additional research also assessed the risk of certain physical effects on the user and observational data from 16 patients provided support for the use of the device on various walking surfaces in the home and community with various levels of assistance from a trained companion.

Argo Medical Technologies, Inc., the manufacturer of ReWalk, will be required by the FDA to complete a post-market clinical study of 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.

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