FDA recall Z-0467-2022

Ki Mobility Llc · Class III · device

Product

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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2021-11-19
Report date
2022-01-19
Termination date
2022-10-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Stevens Point, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0467-2022