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510(k) K250904

Atalante X by Wandercraft SAS — Product Code PHL

K250904 is an FDA 510(k) premarket notification submitted by Wandercraft SAS for the device "Atalante X". The FDA issued a decision of Substantially Equivalent on October 24, 2025. The device falls under product code PHL (Powered Exoskeleton), a Class II device regulated under 21 CFR 890.3480. Wandercraft SAS has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2025
Date Received
March 26, 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 by Wandercraft SAS

  • K260381 — Eve (August 3, 2026)
  • K232077 — Atalante X (December 13, 2023)
  • K221859 — Atalante (December 29, 2022)

Other clearances for product code PHL

  • K260381 — Eve (August 3, 2026)
  • 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)
  • K201559 — HAL for Medical Use(Lower Limb type) (October 2, 2020)

FDA data resources