Trexo Theo FDA Clearance for Supervised Home Use

Trexo Theo FDA clearance arrived on September 2 for a powered exoskeleton intended for supervised ambulatory use. The prescription device's indication covers patients age 12 and older with cerebral palsy.[1][2]

Trexo says US shipments will begin in 2027. It has not posted a device price.[3]

What the clearance covers

The FDA database identifies Theo as a powered exoskeleton under product code PHL. Its 510(k) decision says the device is substantially equivalent to a legally marketed device.[1]

Trexo's indication permits community use under a companion certified through its training program. Clinical use requires supervision by a certified therapist.[2] The company says a companion or therapist must remain within arm's reach throughout each session.

"The Trexo Theo is not intended for sports or stair climbing."[2]

The device also requires a prescription. Trexo lists seven contraindications.[2] They include weight bearing restrictions, severe spasticity and an inability to communicate pain or discomfort. Those limits confine the clearance to a defined patient group and supervised use. Buyers assessing the supervision requirement can also consult our ISO cobot safety standards guide.

Shipping comes later

Clearance permits US marketing, but it does not put devices in homes yet. Trexo's US site says shipping begins in 2027 and directs families to reserve a place in its queue.[3] The company says it will confirm pricing in writing before a purchase agreement. It does not publish a list price or a 2027 shipment total.

Earlier FDA action covered other models

The clearance follows an earlier regulatory dispute involving different Trexo devices. In February 2024, FDA warned Trexo Robotics Holdings that the company had commercially distributed Trexo Home and Trexo Plus without the required premarket notification. The letter also described quality system violations found during a 2023 inspection.[4]

A separate Class 2 recall for those two models remains listed as open in FDA's database. That record covers 357 devices and cites electrical issues that could stop a device, interfere with nearby equipment or create a burn risk.[5]

Neither record names Trexo Theo. The new clearance applies to Theo. The short FDA listing does not give the current status of the older warning letter findings.[1][4] For a separate example of how product capabilities and use cases are described, see our robot mower slope ratings explainer.

Trexo Theo FDA clearance FAQ

Frequently asked questions

What does Trexo Theo FDA clearance cover?

The FDA clearance covers ambulatory functions for patients age 12 and older with cerebral palsy, with the supervision described by Trexo.

When will Trexo Theo ship in the United States?

Trexo says US shipments will begin in 2027. It has not posted a device price.