Last updated: 2026-09-21
In August 2026, the U.S. Food and Drug Administration cleared a Class II powered lower-extremity exoskeleton pathway for hands-free, self-balancing walking and everyday tasks in limited indoor and building-linked spaces, with a specially trained companion, for eligible adults who can operate a controller and tolerate standing.
In September 2026, a U.S. commercial launch was announced for that personal pathway (company-reported). Clearance and launch are news about a capability class — not a brand you must invent, and not proof every home already has one.
Indications for this class still exclude sports and stair climbing. Prescription, assessment, training, and companion supervision remain part of the cleared pathway. Substantial equivalence is a regulatory bar — not a trophy that “best mobility for everyone” is finished.