510(k) clearance
Trexo Theo
- 510(k) number
- K254198
- Applicant
- Trexo Robotics, Inc.
- Decision date
- Sep 2, 2026
- Date received
- Dec 23, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PHL
- Device type
- Powered Exoskeleton
- Device class
- Class II
- Regulation
- 21 CFR 890.3480
- Advisory committee
- Physical Medicine
- Statement or summary
- Summary
- Third party
- N
- Location
- Mississauga, CA