FDA 483 - Electro Kinetic Technologies, LLC - February 15, 2019

An FDA inspection of Electro Kinetic Technologies, LLC in Germantown, WI, identified one observation related to device history records. The firm failed to include or refer to the location of a unique device identifier (UDI) or universal product code (UPC) in their device history records for a Class II patient transport chair. This indicates a deficiency in their UDI implementation for medical devices.