Cleared Traditional

Honda Walking Assist Device (K181294) - FDA 510(k) Clearance

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

K181294 · Honda Motor Company, Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
212d
Days
Class 2
Risk

K181294 is an FDA 510(k) clearance for the Honda Walking Assist Device. Classified as Powered Exoskeleton (product code PHL), Class II - Special Controls.

Submitted by Honda Motor Company, Ltd. (Wako-Shi, JP). The FDA issued a Cleared decision on December 14, 2018 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 Honda Motor Company, Ltd. devices

Submission Details

510(k) Number K181294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2018
Decision Date December 14, 2018
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.

Regulatory Consultant

American Honda Motor Company, Inc.
Mark DiPietro

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT01994395 Completed Interventional

Development of Walk Assist Device to Improve Community Ambulation

Randomized Control Trial Comparing Walking Task Specific Training With Stride Management Assist (SMA) Device vs.Functional Task Specific Training on Functional Walking Ability in Outpatient Stroke Rehabilitation

53
Patients (actual)
1
Site
Treatment
Purpose
Single blind
Masking
Condition studied Stroke
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Arun Jayaraman, PhD
Sponsor Shirley Ryan AbilityLab
Started 2013-10-01 → Primary completion 2020-02-01
Primary outcome
Change in 10 Meter Walk Test From Baseline in Gait Speed
Secondary outcome
Activities-Specific Balance Confidence Scale (ABC)
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 K181294.
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