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Red Oak Instruments, LLC, a manufacturer and distributor of the AC Powered Dynamometer RU-Fit (Model SR-3053) medical device, was cited for marketing an unapproved and misbranded device without an effective premarket approval (PMA) application or investigational device exemption (IDE). The FDA inspection conducted July 15-26, 2024, identified that the company introduced or delivered the device into interstate commerce for commercial distribution with major changes or modifications that were not properly documented or approved. The device violated section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act by lacking required premarket approval and section 502(o) for misbranding violations related to undisclosed modifications.