Neuro Kinetics, Inc. – FDA Warning Letter, Oct 10, 2007

The FDA issued a Warning Letter to Neuro Kinetics, Inc. following inspections on August 15, 16, 21, 2007, and October 10, 2007, and a telephone conversation on August 21, 2008. The firm is marketing Neuro-Otological Test Center products, including the Rotary/Barany Chair Assembly, I-Portal Video Nystagmograph, Opto-Kinetic Projection System, Pursuit Tracker Laser Diode Stimulus, and VEST 6.0 Operating Software, without marketing clearance or approval.

These products are classified as devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). A significant change was made to the Rotary/Barany Chair Assembly (cleared under K781268), specifically, the control mechanism shifted from minimal to extensive software control, constituting a major redesign requiring a new 510(k) submission due to new safety and effectiveness questions.

The devices are adulterated under section 501(f)(1)(B) of the Act because there is no approved premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) of the Act for failure to notify the FDA of intent to introduce the devices into commercial distribution as required by section 510(k).