Recall Z-0467-2022— Ki Mobility Llc
Class III · Terminated
Class III FDA medical device recall by Ki Mobility Llc, initiated 2021-11-19, terminated 2022-10-31. FDA's recall record names no specific 510(k) clearance for this event. 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: The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters..
- Recalling firm
- Ki Mobility Llc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2021-11-19
- Terminated
- 2022-10-31
- Firm location
- Stevens Point, WI, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.