483
Max Mobility LLCMax Mobility LLC – FDA 483, Apr 16, 2026
Record Details
An FDA inspection of Max Mobility LLC in Lebanon, TN, a specification developer, revealed significant deficiencies in their procedures for controlling design and development changes. The firm failed to adequately evaluate changes affecting the safety and function of their SmartDrive Power Assist device, leading to a Class I recall for a SpeedControl dial design change and inadequate verification of new mobile and smartwatch applications.
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