Cleared Traditional

K232077 - Atalante X

K232077 is an FDA 510(k) clearance for Atalante X, manufactured by Wandercraft SAS. The device is a Class 2 Neurology device with product code PHL cleared through the Traditional 510(k) pathway after a 153-day FDA review.

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

K232077 is an FDA 510(k) clearance for the Atalante X. Classified as Powered Exoskeleton (product code PHL), Class II - Special Controls.

Submitted by Wandercraft SAS (Paris, FR). The FDA issued a Cleared decision on December 13, 2023 after a review of 153 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.3480 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wandercraft SAS devices

FDA 510(k) Submission Details - K232077

510(k) Number K232077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 148d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PHL Device Classification - Class 2, Special Controls

Product Code PHL Powered Exoskeleton
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - PHL Powered Exoskeleton

All 16
Devices cleared under the same product code (PHL) and FDA review panel - the closest regulatory comparables to K232077.
Atalante X
K250904 · Wandercraft SAS · Oct 2025
ReWalk® 7 Personal Exoskeleton (50-20-0005)
K241822 · Rewalk Robotics Ltd. Dba Lifeward · Mar 2025
Medical HAL Lower Limb Type (HAL-ML)
K233695 · Cyberdyne, Inc. · May 2024
ReWalk P6.0
K221696 · Re Walk Robotics , Ltd. · Mar 2023
Atalante
K221859 · Wandercraft SAS · Dec 2022
EksoNR
K220988 · Ekso Bionics, Inc. · Jun 2022