PAE · Class II · 21 CFR 890.3450

FDA Product Code PAE: Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography

Upper Extremity Prosthesis Intended To Replace Partially Or Fully Amputated Or Congenitally Absent Upper Extremities And To Provide Multiple And Simultaneous Degrees Of Freedom And Functionality.

1
Total
0
Cleared
693d
Avg days
2014
Since

FDA 510(k) Cleared Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography Devices (Product Code PAE)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code PAE - Regulatory Context