FDA-Device2022-01-19Class III
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.
Ki Mobility Llc
Hazard
The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.
Sold states
Domestic: IL, IN, KY, MI, MO, NC, SC, and TN.
Affected count
33 units shipped with affected manuals
Manufactured in
5201 Woodward Dr, N/A, Stevens Point, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0467-2022Don't want to check this manually?
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