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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:190755

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 recall number

Z-0467-2022

Evidence summary

Product code
INM
Recall status
Terminated
Event initiated
November 19, 2021
Root cause
Process design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0467-2022