Trexo Robotics wins FDA clearance for pediatric home-use exoskeleton

Trexo Robotics received FDA 510(k) clearance for Trexo Theo, a pediatric robotic exoskeleton cleared for home use as well as rehabilitation centers and hospitals in the U.S. The clearance opens a new U.S. market for the Mississauga company as it celebrates 10 years in business and expands in Europe.

Why it matters: - FDA clearance gives Trexo Robotics a path to sell Trexo Theo in the U.S. for home use, pediatric rehabilitation centers and hospitals. - The clearance could expand access to supported walking for children with physical disabilities, which Trexo says can help with confidence, inclusion, movement and neuroplasticity. - Trexo says the U.S. launch will give children access to more consistent movement in settings where families spend the most time.

What happened: - Trexo Robotics announced FDA 510(k) clearance for Trexo Theo, a pediatric robotic exoskeleton. - The company says Trexo Theo is the first pediatric robotic exoskeleton cleared for home use. - The announcement came Sept. 10, 2026, from Mississauga, Ontario. - Trexo also marked its 10th anniversary in July and said it expanded into the EU and U.K. this year.

The details: - Trexo Theo is designed to help children with physical disabilities walk at home. - The device is also cleared for use in pediatric rehabilitation centers and hospitals in the U.S. - Trexo says the FDA process included usage data collection, feature documentation and question-and-answer sessions with regulators. - The company says the final submission contained thousands of pages of information. - Trexo says there are 580 Trexo devices in use worldwide. - Those devices have generated more than 178 million collective steps for children who use them. - Trexo Theo can be customized to a child's size, strength, range of motion and goals. - The device includes adjustable gait parameters and multiple walking modes, including backwards walking. - Trexo Theo supports upright positioning, shifting weight with steps and standing-frame use. - The company says the device is intended to help children build strength and improve endurance at home. - Trexo says it continues to build clinical evidence through partnerships with pediatric rehabilitation centers globally. - Co-founder and CEO Manmeet Maggu said the clearance is not just a regulatory win and reflects the value of consistent, supported movement at home. - Co-founder and CTO Rahul Udasi said the clearance followed rigorous testing and support from families and clinicians in Trexo's community.

Between the lines: - The clearance suggests Trexo is moving from a niche assistive-tech product toward a broader clinical and home-care platform. - Home-use clearance is especially important because it lowers the gap between therapy sessions and daily movement, which can matter for families managing long-term mobility needs. - Trexo's emphasis on evidence, safety and accessibility appears aimed at building trust with clinicians, regulators and payers as it scales.

What's next: - Trexo is inviting families and clinics to contact the company and join a waitlist for Trexo Theo. - The company is likely to use the FDA clearance to accelerate U.S. expansion while continuing clinical partnerships abroad. - Trexo's broader rollout in the EU and U.K. may become part of its next phase of international growth.

The bottom line: - Trexo Robotics has turned a decade of development into a key regulatory win that could make pediatric robotic walking more available at home and in clinical settings.