Trexo Theo— 510(k) K254198

Name: FDA 510(k) clearance K254198
Creator: U.S. Food and Drug Administration
Published: 2026-09-02

Substantially Equivalent

Trexo Robotics, Inc.

FDA 510(k) clearance K254198 for Trexo Theo, Substantially Equivalent on 2026-09-02. Applicant: Trexo Robotics, Inc.. Device class: 2.

Summary

Trexo Theo is from Trexo Robotics, Inc., filed under product code PHL (Powered Exoskeleton). Beyond the name and code, the record says nothing about the device.

Class II, 21 CFR 890.3480. The Neurology review panel handled it as a Traditional 510(k), though the record lists Physical Medicine as the classification panel. The decision was Substantially Equivalent.

Trexo filed from Mississauga, Canada. The decision came 253 calendar days after FDA received it (December 23, 2025 to September 2, 2026).

Clearance details

Applicant: Trexo Robotics, Inc.
Product code: Product code PHL
Device class: Class 2
Regulation: 21 CFR 890.3480
Advisory panel: Physical Medicine
Date received: 2025-12-23
Decision date: 2026-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.