Product code IOR

Device name

Wheelchair, Mechanical

Medical specialty

Physical Medicine

Device class

1

Regulation number

890.3850

Review panel

PM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

A mechanical wheelchair is a manually 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/or require an assistive device for mobility.

Source

FDA openFDA device classification dataset