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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Exoskeleton
510(k) Number K254198
Device Name Trexo Theo
Applicant
Trexo Robotics, Inc.
6705 Milcreek Dr.
Unit 3
Mississauga,  CA L5N 5M4
Applicant Contact Linda Wu
Correspondent
Trexo Robotics, Inc.
6705 Milcreek Dr.
Unit 3
Mississauga,  CA L5N 5M4
Correspondent Contact Linda Wu
Regulation Number890.3480
Classification Product Code
PHL  
Date Received12/23/2025
Decision Date 09/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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