IMK

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Wheelchair, Stair Climbing

Device class

Class II (moderate risk)

Regulation

21 CFR 890.3890

Medical specialty

Physical Medicine

FDA 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.

Adverse events (MAUDE)

2006: 3 · 2007: 8 · 2008: 12 · 2009: 11 · 2010: 5 · 2011: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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