Regulatory information

Regulatory information

The Ekso GT exoskeleton was CE marked as a class IIa device in 2012 and this certification was renewed in 2016. The current version of Ekso has been developed from older versions that did not have the SmartAssist software, and these are also CE marked under the same certification.

A search of the Medicines and Healthcare products Regulatory Agency (MHRA) website revealed that no manufacturer Field Safety Notices or Medical Device Alerts have been issued for this technology.