510(k) clearances

Trexo Theo

Trexo Robotics, Inc. · Physical Medicine

K254198Substantially EquivalentTraditionalPHL
Open FDA's page for this record
Third party flag
N
City
Mississauga
Advisory committee description
Physical Medicine
Address 1
6705 Milcreek Dr.
Address 2
Unit 3
Statement or summary
Summary
Product code
PHL
Zip code
L5N 5M4
Applicant
Trexo Robotics, Inc.
Decision date
2026-09-02
Decision code
SESE
Country code
CA
Device name
Trexo Theo
Advisory committee
PM
Contact
Linda Wu
K number
K254198
Date received
2025-12-23
Review advisory committee
NE
Postal code
L5N 5M4
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Powered Exoskeleton
Medical specialty description
Physical Medicine
Regulation number
890.3480
Device class
2
Registration number
3011819880, 3018091330, 3009767053, 3015000676, 3034724466, 3007615665, 3014209670, 3009495988
FEI number
3011819880, 3018091330, 3009767053, 3015000676, 3034724466, 3007615665, 3014209670, 3009495988
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.