First powered exoskeleton approved for general use
- Who
- ReWalk Personal, ReWalk
- What
- First
- Where
- United States (Philadelphia)
- When
- 26 June 2014
The first powered exoskeleton to gain regulatory approval for use outside of clinical settings is the ReWalk Personal, which was approved for home and public use by the United States Food and Drug Administration on 26 June 2014.
In the United States, powered exoskeletons are classified as Neuromodulation and Physical Medicine Devices, and are therefore strictly regulated by the US Food and Drug Administration (FDA). Other countries subject such devices to similar scrutiny, but FDA approval is generally seen as the most important, as the US is the largest potential market for medical technology overseen by a single regulator. The ReWalk was developed by Israeli technology firm ReWalk Robotics (originally Argo Medical Technologies).
Clinical trials of the ReWalk began in 2009 at the MossRehab physical rehabilitation hospital in Philadelphia, Pennsylvania, USA. This early version of the exoskeleton was cleared for use in clinical settings in 2011, and began being trialled for unsupervised home use from 2012.