Cleared Traditional

K260381 - Eve

K260381 is an FDA 510(k) clearance for Eve, 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 179-day FDA review.

K260381 · Wandercraft SAS · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
179d
Days
Class 2
Risk

K260381 is an FDA 510(k) clearance for the Eve. Classified as Powered Exoskeleton (product code PHL), Class II - Special Controls.

Submitted by Wandercraft SAS (Paris, FR). The FDA issued a Cleared decision on August 3, 2026 after a review of 179 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 - K260381

510(k) Number K260381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2026
Decision Date August 03, 2026
Days to Decision 179 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
31d slower than avg
Panel avg: 148d · This submission: 179d
Pathway characteristics
Predicate-based equivalence.

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. 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
NCT06777576 Recruiting Interventional Industry-sponsored

Self-balancing Personal Exoskeleton for SCI

Empowering Mobility in People With Spinal Cord Injury With a Hands-free, Self-balancing Personal Exoskeleton

24
Patients (est.)
1
Site
Other
Purpose
Open label
Masking
Condition studied Spinal Cord Injuries (SCI); Paraplegia and Tetraplegia
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Wandercraft (industry)
Started 2025-02-12 → Primary completion 2026-05-31
Primary outcome
Proportion of subjects who complete the Timed Up and Go (TUG) in 3min or less.
Secondary outcome
Proportion of subjects who can complete at least 4 out of the 6 Activities of Daily Living (ADLs), in various simulated environments and with the exoskeleton.
View full study on ClinicalTrials.gov

Regulatory Peers - PHL Powered Exoskeleton

All 24
Devices cleared under the same product code (PHL) and FDA review panel - the closest regulatory comparables to K260381.
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
Atalante X
K232077 · Wandercraft SAS · Dec 2023
ReWalk P6.0
K221696 · Re Walk Robotics , Ltd. · Mar 2023
Atalante
K221859 · Wandercraft SAS · Dec 2022