Trexo Theo— 510(k) K254198

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.

Clearance details

Applicant: Trexo Robotics, Inc.
Product code: 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.