Cleared Traditional

Atalante

K221859 · Wandercraft SAS · Neurology
Dec 2022
Decision
185d
Days
Class 2
Risk

About This 510(k) Submission

K221859 is an FDA 510(k) clearance for the Atalante, a Powered Exoskeleton (Class II — Special Controls, product code PHL), submitted by Wandercraft SAS (Paris, FR). The FDA issued a Cleared decision on December 29, 2022, 185 days after receiving the submission on June 27, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 890.3480.

Submission Details

510(k) Number K221859 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2022
Decision Date December 29, 2022
Days to Decision 185 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.