ReWalk Exoskeleton Gets FDA Clearance for Home Use

The ReWalk Personal System has gotten clearance from the U.S. Food & Drug Administration (FDA) to be used by consumers in their homes, its manufacturer has announced.

The ReWalk is a wearable robotic exoskeleton that its manufacturer, ReWalk Robotics - formerly Argo Medical Technologies - describes as providing "powered hip and knee motion to enable individuals with spinal cord injury to stand upright and walk."

ReWalk Robotics also says the system "provides user-initiated mobility through the integration of a wearable brace support, a computer-based control system and motion sensors. The system allows independent, controlled walking while mimicking the natural gait patterns of the legs, similar to that of an able-bodied person."

After donning the ReWalk, the consumer uses forearm crutches to walk. The ReWalk user moves both crutches forward, then takes a step, in a "double-crutch" pattern.

In speaking to The Mobility Project last year about various exoskeletons she had tested, Clare Hartigan, MPT, BSBio, said, "The ReWalk can only be used with forearm crutches. Two crutches at a time, step. Two crutches at a time, step. It's not a normal, reciprocal gait pattern of arm, leg, arm, leg. So with the ReWalk, you cannot use a walker."

ReWalk systems designed for individual consumer use will be custom fitted to each user, the manufacturer said. The personal system will accommodate users from 63 to 75 inches tall and weighing up to 220 lbs. The manufacturer also says users need to be able to use their hands and shoulders to maneuver the crutches and need healthy cardiovascular systems and adequate bone densities to use ReWalk.

About the Author

Laurie Watanabe is the editor of Mobility Management. She can be reached at lwatanabe@1105media.com.

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