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510(k) K254198

Trexo Theo by Trexo Robotics, Inc. — Product Code PHL

K254198 is an FDA 510(k) premarket notification submitted by Trexo Robotics, Inc. for the device "Trexo Theo". The FDA issued a decision of Substantially Equivalent on September 2, 2026. The device falls under product code PHL (Powered Exoskeleton), a Class II device regulated under 21 CFR 890.3480.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2026
Date Received
December 23, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powered Exoskeleton
Device Class
Class II
Regulation Number
890.3480
Review Panel
NE
Submission Type

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.

Other clearances for product code PHL

  • K260381 — Eve (August 3, 2026)
  • K250904 — Atalante X (October 24, 2025)
  • K241822 — ReWalk® 7 Personal Exoskeleton (50-20-0005) (March 12, 2025)
  • K233695 — Medical HAL Lower Limb Type (HAL-ML) (May 7, 2024)
  • K232077 — Atalante X (December 13, 2023)
  • K221696 — ReWalk P6.0 (March 2, 2023)
  • K221859 — Atalante (December 29, 2022)
  • K220988 — EksoNR (June 9, 2022)
  • K213452 — GEMS-H (April 21, 2022)
  • K201473 — ExoAtlet-II (July 16, 2021)

FDA data resources