AMBLE enters the US medical-device identification database
NextStep Robotics listed AMBLE in the US AccessGUDID medical-device database as a commercially distributed powered exerciser.
Evidence notes
- The public device record identifies NextStep Robotics as the manufacturer of AMBLE model 0644.
- AMBLE is a body-worn powered exerciser intended to restore ankle function during walking.
- AccessGUDID lists AMBLE as prescription-only and in commercial distribution under FDA product code BXB.
Company context
NextStep Robotics develops personalised robotic therapy for people with foot drop following stroke or neurological injury. Its clinic-based system adapts assistance to patient movement and captures progress data during repetitive gait training.