Regulator
The FDA cleared the ReWalk exoskeleton through the De Novo route (DEN130034), creating a new class II (moderate risk) device type for powered exoskeletons. ReWalk was cleared for use at home and in the community.
A regulator's decision · Sets Medical exoskeletons's stage
What the source says
“on June 26, 2014, FDA issued an order to the requestor classifying the device into class II.”
What it means
Medical exoskeletons, from Lifeward (ReWalk), Wandercraft, Ekso Bionics (owned by Wandercraft since Oct 2026), is at stage 5 of 5 on our ladder: regulator-cleared or mass market. This event is one of the milestones that placed it there.
Human help: A staff member rides along, ready to stop it.
More on Medical exoskeletons
- Wandercraft bought Ekso Bionics from ChronoScale and said it would keep supporting Atalante X, EksoNR, Eve and Indego Personal. The price was not disclosed.
- Wandercraft said the FDA cleared Eve, a self-balancing exoskeleton for personal use, for adults with spinal cord injuries at any level, used with a trained companion.
- Ekso's parent company, renamed ChronoScale and moving into cloud computing, said it would sell the Ekso exoskeleton business.
- The FDA cleared the ReWalk 7 Personal Exoskeleton from Lifeward (510(k) K241822) for indoor and outdoor walking, including stairs and curbs.
- Medicare set a payment rate for personal exoskeletons for home use, starting with the ReWalk Personal and the Indego Personal.
- Ekso Bionics bought the Indego exoskeleton business from Parker Hannifin for $10 million.