Trexo Robotics Illegally Marketing Devices: FDA

A 6/3-6/5/2023 FDA inspection at Trexo Robotics Holdings in Mississauga, Ontario, Canada, found that the firm manufactures the Trexo Home and Trexo Plus medical devices that are adulterated because they do not have an approved PMA or IDE in place. A just-released 2/7 Warning Letter says the devices also are misbranded because the firm did not notify the agency of its intent to introduce them into interstate commerce without submitting a premarket notification.

The letter says the firm listed its devices under a classification of Isokinetic Testing and Evaluation System, but FDA has determined that the Trexo devices are intended for uses that are different from those of legally marketed devices in that classification. Thus, it says, while devices classified under Isokinetic Testing and Evaluation System are rehabilitative exercise devices intended for medical purposes, Trexo devices are being marketed as a robotic-powered gait training device to assist children with different levels of disability with ambulatory functions such as walking and standing.

FDA says the inspection also found these Quality System Regulation violations:

• failure to adequately establish and maintain procedures to control the design of the device to ensure that specified design requirements are met;
• failure to adequately establish and maintain procedures requiring that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures;
• failure to adequately establish and maintain procedures for implementing corrective and preventive action; and
• company procedures do not ensure that all complaints are handled as complaints instead of as feedback.

The letter says the company’s responses to the QS observations are inadequate or cannot be assessed.

FDA asked that the company cease any activities that result in the misbranding or adulteration of the Trexo devices, such as the commercial distribution of the devices for the described uses. Trexo was told to take prompt action to address violations identified in the letter and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the steps and a schedule for completing the corrections.