Powered exoskeletons could easily become machines that move a person around, which is not the same as giving the person a usable command loop. ReWalk's problem was to make walking in a rigid powered frame intentional, repeatable, and trainable.

The clever control choice was to use torso lean and weight shift as the input. The device sensed a forward tilt, powered the first step, then used repeated shifts to continue gait. That mapped the command to a movement the user already needed to make.

The product path was also staged. ReWalk Rehabilitation launched for clinical settings in 2011, ReWalk Personal entered Europe after CE mark clearance at the end of 2012, and FDA granted De Novo classification for REWALK on June 26, 2014.

Make body lean the walking command

The tilt sensor reduced the gap between intention and machine command.

Starting in rehabilitation centers created training sites for eventual personal use.

De Novo classification gave the novel device a U.S. regulatory path with special controls rather than forcing it into a mismatched predicate category.

For assistive robotics, the interface can be the user's natural preparatory motion rather than a separate control panel.

ReWalk's 2015 filing says 104 units were in rehabilitation centers and 107 in home or community use by December 31, 2015. It also notes the limits clearly: users needed specific physical criteria, training, crutches, and a trained companion under FDA specifications.

FOLLOW THE EVIDENCE

The sources

  1. Device Classification Under Section 513(f)(2)(De Novo): REWALK accessdata.fda.gov
  2. Form 10-K, ReWalk Robotics Ltd., fiscal year 2015 sec.gov