Zdrowie i gospodarka · 18/10/2016

FDA Classifies Upper Extremity Prosthesis into Class II with Special Controls

The FDA has classified the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder with Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components into Class II, requiring special controls to ensure safety and effectiveness.