Class III — Ki Mobility Llc
| Recalling firm | Ki Mobility |
|---|---|
| Registered facility | Ki Mobility (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters. |
| 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. |
| Quantity | 33 units shipped with affected manuals |
| Distribution | Domestic: IL, IN, KY, MI, MO, NC, SC, and TN. |
| Initiated | 2021-11-19 |
| Classified | 2022-01-07 |
| Terminated | 2022-10-31 |
| Recall number | Z-0467-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Ki Mobility Llc (Z-0467-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89204/
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