Cleared Traditional

K250904 - Atalante X (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence.

K250904 · Wandercraft SAS · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
212d
Days
Class 2
Risk

K250904 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 October 24, 2025 after a review of 212 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

Submission Details

510(k) Number K250904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 148d · This submission: 212d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04187209 Completed Interventional Industry-sponsored

Evaluation of the Use of the Atalante System in Patients Presenting a Non-traumatic Hemiplegia in Acute-subacute Phase (15 Days to 6 Months).

14
Patients (actual)
3
Sites
Other
Purpose
Open label
Masking
Condition studied Stroke; Stroke, Acute; Stroke, Subacute; Robotics
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Jacques Kerdraon, Dr
Sponsor Wandercraft (industry)
Started 2019-09-11 → Primary completion 2021-01-13
Primary outcome
Evaluate the use of the Atalante system in patients with non-traumatic acute-subacute hemiplegia over several sessions with a 10 meter Walk Test. This test will show the incidence of test success and emergence of adverse events.
Secondary outcome
Evaluate the patient's ambulatory ability without the Atalante exoskeleton with the Functional Ambulation Classification (FAC).
Study completed - no results published. This trial concluded in 2021 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - PHL Powered Exoskeleton

All 23
Devices cleared under the same product code (PHL) and FDA review panel - the closest regulatory comparables to K250904.
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
Atalante X
K232077 · Wandercraft SAS · Dec 2023
ReWalk P6.0
K221696 · Re Walk Robotics , Ltd. · Mar 2023
Atalante
K221859 · Wandercraft SAS · Dec 2022
EksoNR
K220988 · Ekso Bionics, Inc. · Jun 2022