Ki Mobility Llc recalls Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated…

Recall date

November 19, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0467-2022

FDA classification

Class III

Brand / firm

Ki Mobility Llc

Sold / distributed

Domestic: IL, IN, KY, MI, MO, NC, SC, and TN.

Why it was recalled

The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport.