FDA approval - not an easy task. (Food and Drug Administration)(Brief Article)

Design News, June, 1998

Cleveland, OH--For 20 years, Jim Jatich was completely dependent on others for everything, eating, shaving, combing his hair. Today, he talks on the phone, works on a computer, pours his own drinks thanks to Functional Electronic Stimulation (FES).

The Freehand, a FES device developed at Cleveland FES Center and offered commercially by NeuroControl, gives a person the ability to use either a lateral or palmer grasp via a shoulder control system.

"The real challenge engineering-wise was to move this device from prototype to mass production for commercial use," says Geoffrey Thrope, vice president of NeuroControl.

For the clinical trials, NeuroControl developed a standardized data collection system that proved the patient had no...