Product code KFW

Device name

Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Powered

Medical specialty

Physical Medicine

Device class

1

Regulation number

890.3420

Review panel

PM

Implant

N

Life sustaining/supporting

N

GMP exempt

Y

Third party review

N

Summary malfunction reporting

Eligible

Source

FDA openFDA device classification dataset