Ki Mobility Llc 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.

Recommended Action

Per FDA guidance

The firm distributed a Medical Device Correction Notice dated 12/07/2021 by first class mail to consignees. The notificaiton identified the reason for recall as the Owner's Manual/Instructions for Use for the Little Wave Tyke contained information intended for a mechanical wheelchair, not a mechanical chair with casters. Customers were instructed to distribute the provided updated Little Wave Tyke Owner's Manual/Instructions for Use (DCN0569.2) to end users, and if available request that customers destroy or dispose of the previous versions of the manual (DCN0569.0 and DCN0569.1). The updated manual is available in print or on the company's website (kimobility.com). Customers with any questions are asked to contact the firm by email at sales@kimobility.com, or by phone at (715)254-0991 or (800)981-1540.

Distribution

As reported by FDA

IL, IN, KY, MI, MO, NC, SC, TN