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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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