Cleared Traditional

Atalante X

K232077 · Wandercraft SAS · Neurology
Dec 2023
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K232077 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, FR). The FDA issued a Cleared decision on December 13, 2023, 153 days after receiving the submission on July 13, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 890.3480.

Submission Details

510(k) Number K232077 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2023
Decision Date December 13, 2023
Days to Decision 153 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.