Product code ITI

Device name

Wheelchair, Powered

Medical specialty

Physical Medicine

Device class

2

Regulation number

890.3860

Review panel

PM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).

Source

FDA openFDA device classification dataset