Cleared Traditional

Atalante X

K250904 · Wandercraft SAS · Neurology
Oct 2025
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K250904 is an FDA 510(k) clearance for the Atalante X, a Powered Exoskeleton (Class II — Special Controls, product code PHL), submitted by Wandercraft SAS (Paris, Ile-De-France, FR). The FDA issued a Cleared decision on October 24, 2025, 212 days after receiving the submission on March 26, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 890.3480.

Submission Details

510(k) Number K250904 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2025
Decision Date October 24, 2025
Days to Decision 212 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code PHL — Powered Exoskeleton
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.3480
Definition 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.