# K254198: Trexo Theo

- Pathway: 510(k) (Traditional)
- Applicant: Trexo Robotics, Inc.
- Decided: Sep 2, 2026 after 253 days
- Product code: PHL (Powered Exoskeleton)
- Device class: 2
- Regulation: 21 CFR 890.3480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN130034 (2014). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233695: Medical HAL Lower Limb Type (HAL-ML), Cyberdyne, Inc. (2024) Summary page 5.
- K221696: ReWalk P6.0, Re Walk Robotics, Ltd. (2023) Summary page 5.

## Indications for use
The Trexo Theo is a powered exoskeleton intended to perform ambulatory functions in patients 12 years and older with cerebral palsy. The Trexo Theo is intended to be used in a community setting under the supervision of a trained companion who has been certified to the companion training program prior to use of the device. The device is also intended to be used in a clinical setting under the supervision of a trained therapist who has been certified to the therapist training program prior to use of the device. The Trexo Theo is not intended for sports or stair climbing.

Source page: https://510kreport.com/device/K254198
Methodology: https://510kreport.com/methodology