Cleared Traditional

K140886 - WALKAIDE SYSTEM

K140886 is an FDA 510(k) clearance for WALKAIDE SYSTEM, manufactured by Innovative Neurotronics, Inc.. The device is a Class 2 Neurology device with product code GZI cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K140886 · Innovative Neurotronics, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
123d
Days
Class 2
Risk

K140886 is an FDA 510(k) clearance for the WALKAIDE SYSTEM. Classified as Stimulator, Neuromuscular, External Functional (product code GZI), Class II - Special Controls.

Submitted by Innovative Neurotronics, Inc. (Austin, US). The FDA issued a Cleared decision on August 8, 2014 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5810 - 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.

FDA 510(k) Submission Details - K140886

510(k) Number K140886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2014
Decision Date August 08, 2014
Days to Decision 123 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
26d faster than avg
Panel avg: 149d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

GZI Device Classification - Class 2, Special Controls

Product Code GZI Stimulator, Neuromuscular, External Functional
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5810
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
NCT01087957 Completed Interventional Industry-sponsored

WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients

Randomized Trial of the Innovative Neurotronics WalkAide Compared to Conventional Ankle-Foot Orthosis (AFO) in Stroke Patients (INSTRIDE)

495
Patients (actual)
29
Sites
Treatment
Purpose
Open label
Masking
Condition studied Stroke
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Francois Bethoux, M.D.
Sponsor Innovative Neurotronics (industry)
Started 2010-03-01 → Primary completion 2012-02-01 → Completed 2013-06-01
Primary outcome
Gait Velocity
Secondary outcome
Six Minute Walk Test
View full study on ClinicalTrials.gov

Regulatory Peers - GZI Stimulator, Neuromuscular, External Functional

All 55
Devices cleared under the same product code (GZI) and FDA review panel - the closest regulatory comparables to K140886.
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