DeviceClearance

Product code PAE— Physical Medicine

DEKA ARM SYSTEM

Classification name
Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography
Device class
Class 2
Regulation
21 CFR 890.3450
Advisory panel
Physical Medicine
Total cleared
1
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code PAE under 21 CFR 890.3450, via openFDA

Market context for product code PAE

FDA has cleared 1 device under product code PAE, all in 2014, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PAE

Recent clearances under product code PAE

Data sourced from openFDA. This site is unofficial and independent of the FDA.