Cleared Traditional

K254198 - Trexo Theo

K254198 is an FDA 510(k) clearance for Trexo Theo, manufactured by Trexo Robotics, Inc.. The device is a Class 2 Neurology device with product code PHL cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K254198 · Trexo Robotics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
253d
Days
Class 2
Risk

K254198 is an FDA 510(k) clearance for the Trexo Theo. Classified as Powered Exoskeleton (product code PHL), Class II - Special Controls.

Submitted by Trexo Robotics, Inc. (Mississauga, CA). The FDA issued a Cleared decision on September 2, 2026 after a review of 253 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.3480 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Trexo Robotics, Inc. devices

FDA 510(k) Submission Details - K254198

510(k) Number K254198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2025
Decision Date September 02, 2026
Days to Decision 253 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 149d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PHL Device Classification - Class 2, Special Controls

Product Code PHL Powered Exoskeleton
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3480
Definition A Powered Exoskeleton Is A Prescription Device That Is Composed Of An External, Powered, Motorized Orthosis That Is Placed Over A Person's Paralyzed Or Weakened Lower Extremity Limb(s) For Medical Purposes.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - PHL Powered Exoskeleton

All 25
Devices cleared under the same product code (PHL) and FDA review panel - the closest regulatory comparables to K254198.
Eve
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Atalante X
K232077 · Wandercraft SAS · Dec 2023
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K221696 · Re Walk Robotics , Ltd. · Mar 2023