Wandercraft commercially launched Eve, the first FDA-cleared self-balancing personal exoskeleton, on September 17, 2026, making the device available to eligible wheelchair users with spinal cord injuries across the United States4,2.
The Paris-based robotics company's device uses what Wandercraft calls "physical AI" — a system of motorized joints and stabilization algorithms that maintains upright balance automatically, without crutches or a walker5. Users direct movement through a handheld controller, triggering actions such as stepping, stopping, and turning. Practical applications include standing at a kitchen counter, moving through the home, carrying objects, and having eye-level conversations.
Regulatory path and eligibility
The FDA granted 510(k) clearance (K260381) for Eve as a Class II medical device in August 2026, supported by a three-site clinical trial evaluating safety, upright mobility, and usability. Eve is cleared for adults 18 and older with spinal cord injury at any neurological level who can safely operate the controller. That breadth is notable: Eve is the first FDA-cleared device in this category without restrictions based on the neurological level of spinal cord injury.
"FDA clearance showed that Eve was ready to move forward. Today is about making it a reality for the people we built it for," said Matthieu Masselin, co-founder and CEO of Wandercraft.
Eve is designed for level indoor surfaces and immediately adjacent outdoor areas such as patios, and requires supervision by a specially trained companion3. Users must obtain a prescription from a licensed healthcare practitioner, undergo a clinical assessment, get custom-fitted, and complete five two-hour training sessions with their companion.
Distribution and reimbursement
Eve is available through more than 180 National Seating and Mobility locations across the United States. Medicare billing is available under HCPCS code K1007 for users who meet eligibility and medical necessity requirements. Wandercraft expects Eve to be eligible for Medicare reimbursement within 60 to 90 days. Pricing has not been publicly disclosed.
Wandercraft built an earlier rehabilitation model, Atalante X, currently used in more than 150 centers worldwide. Eve brings that same balancing technology from clinical settings into daily home use.
ANALYSIS The transition from rehab-only exoskeletons to a personal, home-use device with broad neurological eligibility marks a concrete expansion of the addressable population for AI-driven assistive robotics.
Wandercraft plans international expansion following the U.S. launch.