Product code IMK

Device name

Wheelchair, Stair Climbing

Medical specialty

Physical Medicine

Device class

2

Regulation number

890.3890

Review panel

PM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

A device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs. 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.

Source

FDA openFDA device classification dataset