Trexo Robotics Receives FDA Clearance; Launches Trexo Theo, First Pediatric Robotic Exoskeleton Cleared for Home Use

Company Celebrates 10th Birthday, Expansion into the EU/UK and Expansion into U.S. Market with FDA 510(k) Clearance

MISSISSAUGA, CANADA, September 10, 2026 /EINPresswire.com/ -- Trexo Robotics announces FDA 510(k) clearance for Trexo Theo, a pediatric robotic exoskeleton designed to empower children with physical disabilities to walk at home. The clearance marks the end of a long period spent gathering usage data, hours documenting features, and question and response sessions with the FDA resulting in thousands of pages of information in the final submission. The Trexo Theo is also cleared for use in pediatric rehabilitation centers and hospitals in the U.S. Trexo Theo launching in the U.S. brings access to consistent movement to children.

2026 is a year of milestones for Trexo. The company celebrated 10 years in July alongside their expansion into the EU and UK.

Since founding, there are 580 Trexo devices worldwide, resulting in more than 178 million collective steps for the children who use the device.

The FDA clearance accelerates the company's mission to remove barriers that currently prevent children from experiencing the confidence, fun, inclusion and neuroplasticity benefits that come from intentional, repetitive walking.

"Ten years ago, we started Trexo when my nephew was told he would never walk. Our excitement and conviction deepened as we watched my nephew walking in his Trexo. Our strong belief is that every child who wants to walk should have the opportunity to do so" said Manmeet Maggu, Co-founder and CEO of Trexo Robotics. "The FDA clearance isn't just a regulatory win, it's recognition that consistent, supported movement at home matters. This is not about the device, it's about the countless families that will experience moments that they haven't yet been able to."

Trexo Theo is customizable to children's size, strength, range of motion, and goals, with adjustable gait parameters and multiple walking modes - including backwards walking. The device supports upright positioning, the shift of weight with steps, and also acts as a standing frame. Trexo Theo enables children to build strength, and improve endurance in the environment they are most comfortable in; home.

The FDA clearance also reflects the growing body of evidence supporting the need for consistent movement for children. Trexo continues to advance clinical evidence through partnerships with leading pediatric rehabilitation centers globally.

Co-Founder Rahul Udasi, Trexo's CTO shared, "This clearance is the result of rigorous testing, a team that is as dedicated to the mission as Manmeet and I are, and the help and support of the families and clinicians in our community. Our unwavering commitment to safety and accessibility is a constant. We are proud to bring Trexo Theo to the families and clinics in the United States."

Interested families and clinics are invited to contact Trexo to learn more, and lock in a spot on the waitlist.

About Trexo Robotics:

Trexo designs and manufactures pediatric robotic exoskeletons, with a vision for the future that is much bigger and broader. Based in Mississauga, Ontario, Trexo serves families and clinical partners globally. For more information visit https://us.trexorobotics.com

Jenn Horowitz
Trexo Robotics
+1 562-784-7711
email us here
Visit us on social media:
LinkedIn
Instagram
Facebook