2 results
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8ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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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.
FDA Enforcement
Class III
·Terminated·Ki Mobility Llc·January 19, 2022
NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
FDA Enforcement
Class III
·Ongoing·NuVasive Inc·February 15, 2023