FDANovember 19, 2021device
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 poun...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.
What to do
FDA enforcement status: Terminated
Brands named
ki mobility
UPCs
00850013379231
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCAdult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Imported by Hepo Care Medical Equipment Online2026-04-30
- CPSCLEACHOI Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violates Mandatory Standard for Adult Portable Bed Rails; Sold on Amazon by LEACHOI2025-10-23
- FDAMax Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.2025-08-12
- FDAMax Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.2025-08-12
- FDAMax Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.2025-08-12
- FDAiBOT PMD with software version 01.05.24. Personal Mobility Device.2025-04-24
- FDAMax Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.2024-12-20
- FDAMax Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.2024-12-20
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