Medical devices & robotics · Pediatric mobility
Trexo Robotics
Powered robotic legs that bolt onto a child’s walker, sold to families since 2017 and used for more than 170 million steps. On September 2, 2026, after an FDA warning letter and two recalls, the company got a clearance. It covers children 12 and older with cerebral palsy.
A prototype in a suitcase
In 2016 two engineers packed a robot into luggage and flew from Toronto to Delhi. It was a pair of motorized legs meant to clamp onto a walker frame and swing a child’s hips and knees through a gait cycle. The child was Praneit, nephew of one of them.
It did not work at first. “Thankfully my brother has a workshop there, so we were able to fix the issues. We watched Praneit take his first steps. That was the proudest moment of my life,” Manmeet Maggu told the University of Waterloo.
That is the origin story, and the company tells it well. The harder story is what happened when a device built for one child became a product shipped to hundreds of homes and clinics across twenty-two countries before a regulator reviewed it.
A gap with almost nothing in it
Children at the severe end of cerebral palsy, Gross Motor Function Classification System levels IV and V, do not walk for mobility. Sitting all day costs them bone density, bowel function, sleep and respiratory health, and the options are thin. An OBIO release on a Canadian hospital evaluation put it bluntly: “There are currently no effective interventions known to improve motor function for children with severe disabilities.”
Robotic gait training existed, but it was treadmill-bound and adult-sized. Hocoma’s Lokomat has held a Canadian device licence since 2002 and lives in rehabilitation hospitals. Nothing comparable was built for a four-year-old in a living room.
Two roommates from Waterloo
Maggu and Rahul Udasi met as roommates in a University of Waterloo dorm and studied mechatronics engineering. Maggu learned of his nephew’s diagnosis in 2011, made the exoskeleton his senior design thesis, and kept prototyping on a $600 3D printer while working at BlackBerry and Qualcomm. They incorporated in 2016, went through Techstars in New York, then Y Combinator’s Winter 2019 batch.
Their choice was to skip the lab. “We soon realized that the best way to have a maximum impact is by building a profitable business out of this,” Maggu told Freethink. TechCrunch spelled out the consequence in 2019: Trexo was marketing the device as exercise and therapy equipment rather than a medical device, which let it sidestep some FDA requirements.
In practice that meant listing Trexo under 21 CFR 890.1925, the rule for isokinetic testing systems: stationary gym machines, exempt from premarket notification. Trexo sold direct to families at $29,900 in 2019, rising to roughly $35,000 to $40,000 Canadian by late 2024, with a $44,900 list price announced. Almost no insurer covered it, and the company’s own help pages still say so: “Trexo Home does not have pre-approved insurance coverage at this time.” Families fundraised instead. Trexo’s news page is largely a list of those campaigns.
The bill comes due
In May 2023 Trexo recalled every Home and Plus unit it had shipped. Health Canada logged the reasons: electromagnetic radiation above the IEC 60601-1-11 threshold in lab testing, and water ingress inside electronics enclosures after IP22 testing. The FDA classified it Class 2, recall Z-2236-2023, 357 units across 22 countries, hazard summarized as “Electrical issues that could potentially render the device non-functional, give off electromagnetic influence to surrounding equipment, and risk of burns when in use.”
FDA investigators inspected the Mississauga plant that June. On February 7, 2024 the agency sent a warning letter finding the devices adulterated and misbranded, with four quality-system failures alongside. The core finding: the Trexo devices were intended for uses different from the exempt category the firm had listed them under.
Trexo filed a traditional 510(k) on December 23, 2025. The FDA cleared it on September 2, 2026 as K254198, Trexo Theo, a powered exoskeleton under 21 CFR 890.3480, Class II. The US site now says shipping begins in 2027.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA clearance | K254198, Substantially Equivalent Sep 2, 2026, product code PHL, Class II. Indication for Use, per the company safety page: “The Trexo Theo is a powered exoskeleton intended to perform ambulatory functions in patients 12 years and older with cerebral palsy.” | Public record |
| Who it covers | Cleared for age 12 and up with cerebral palsy. The devices are sold and studied in children as young as 1 to 3, and marketed for spinal muscular atrophy, muscular dystrophy, stroke, brain injury and Rett syndrome. In the largest published cohort the median age was 6 and 70.8% had cerebral palsy. | Narrower than marketed |
| Warning letter | CMS 673150, Feb 7, 2024, after a June 2023 inspection. Adulterated under 501(f)(1)(B), misbranded under 502(o), plus findings on design control, process validation, CAPA and complaint handling. No close-out letter found. | Public record |
| Recalls | FDA Class 2 recall Z-2236-2023, initiated May 31, 2023, 357 units, open at last posting. Health Canada recall started Jul 31, 2023. | Public record |
| Adverse events | One MAUDE serious injury, Dec 11, 2023: a bone fracture in a child on a second clinic session, which the manufacturer attributes to user error. In the 12-week Calgary study, “Adverse events occurred in less than 1% (16 minor, 1 moderate) of robotic walking sessions.” | Public record |
| Health Canada | No Trexo licence appears in the Medical Devices Active Licence Listing, which covers Class II, III and IV. A 2024 study protocol states the Trexo “is listed as a Class I medical device by Health Canada and Class II medical device by the FDA.” Class I needs no licence in Canada. | Public record |
| What the studies found | Seven peer-reviewed papers, 2021 to 2026, all led by Calgary or Holland Bloorview. The largest, 171 private owners: “Six months of overground robotic walker use resulted in modest, statistically significant improvements in functional ability and secondary outcomes linked to physical inactivity.” | Public record |
| What did not move | In a 2026 Holland Bloorview study of 10 children at GMFCS level IV, “there was no meaningful increase in Gross Motor Function Measure (88 items; mean change +1.0)” and no increase in 1-minute walk distance. | Public record |
| Trials and design | Five ClinicalTrials.gov studies name the Trexo, all sponsored by Calgary or Holland Bloorview, none by Trexo Robotics. No published randomized controlled trial found; every design is observational, single-arm, case or qualitative. | Not found |
| Cost to families | No pre-approved insurance coverage, per the company FAQ. A 2026 study of seven families found that “Finally, parents discussed that obtaining the device was a financial burden for them.” | Company-stated |
Read plainly: the walking is real and the safety signal is small, but the clinical case rests on studies nobody at the company designed, and what moved was activity, sleep, cadence and parent-rated function rather than motor capacity. The clearance covers a slice of the company’s own customer base.
What to watch
- A close-out letter for the February 2024 warning letter, and termination of the 2023 recall.
- A second 510(k) widening the indication below age 12 or beyond cerebral palsy, where most of the installed base sits.
- Results from Calgary trials NCT07405450 and NCT06407219, primary completion listed in 2026.
- A published US price for Trexo Theo, and the first payer to cover one. Shipping starts in 2027.
- Whether Health Canada revisits the Class I designation now that the FDA calls this a Class II powered exoskeleton.
In their words
“Thankfully my brother has a workshop there, so we were able to fix the issues. We watched Praneit take his first steps. That was the proudest moment of my life.”
Manmeet Maggu, co-founder and CEO, University of Waterloo news · Independent
“We soon realized that the best way to have a maximum impact is by building a profitable business out of this.”
Manmeet Maggu, Freethink, 2022 · Independent
“The company is marketing the device as an exercise and therapy device, which means that it can avoid some of the regulatory requirements to bring the product to market under the current regulations from the Food and Drug Administration, which oversees medical devices.”
Jonathan Shieber, TechCrunch, February 2019 · Independent
“FDA has determined that the Trexo devices are intended for uses that are different from those of legally marketed devices in the generic type of device under 21 CFR 890.1925, Isokinetic Testing and Evaluation System.”
FDA warning letter CMS 673150, February 7, 2024 · Public record
“One of our key focuses for the next year or so is improving accessibility.”
Manmeet Maggu, BetaKit, December 2024 · Independent
“Finally, parents discussed that obtaining the device was a financial burden for them.”
Youngblood, Hilderley and Condliffe, Disability and Rehabilitation: Assistive Technology, 2026 · Peer reviewed
Related companies
Sources
- Public recordFDA 510(k) K254198, Trexo Theo
- Public recordFDA classification PHL, 21 CFR 890.3480
- Public recordWarning letter CMS 673150
- Public recordClass 2 Device Recall Z-2236-2023
- Public recordTrexo Home and Trexo Plus recall
- Public recordMAUDE report MW5150483
- Public recordActive Licence Listing queries, Trexo and Lokomat control
- Public recordFive registered studies naming Trexo
- Public recordOverground robotic walker use in the home and community
- Public recordExoskeleton-assisted physiotherapy in school and outpatient contexts
- Public recordRObotic WAlking for children who CAnnot WAlk
- Public recordOverground exoskeleton use, study protocol
- IndependentTrexo Robotics gets a Y Combinator boost
- IndependentTrexo has helped children take 100 million steps
- IndependentThe man building robotic legs for kids with cerebral palsy
- IndependentRobotic exoskeleton helps children take their first steps
- CompanyIndications and safety information
- CompanyClinical evidence and funding pages
- CompanyOur story, FAQ and news index
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
