Cleared Traditional

K171334 - Indego

K171334 is an FDA 510(k) clearance for Indego, manufactured by Parker Hannifin Corporation. The device is a Class 2 Neurology device with product code PHL cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K171334 · Parker Hannifin Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
123d
Days
Class 2
Risk

K171334 is an FDA 510(k) clearance for the Indego. Classified as Powered Exoskeleton (product code PHL), Class II - Special Controls.

Submitted by Parker Hannifin Corporation (Macedonia, US). The FDA issued a Cleared decision on September 8, 2017 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 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 Parker Hannifin Corporation devices

FDA 510(k) Submission Details - K171334

510(k) Number K171334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2017
Decision Date September 08, 2017
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.

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.

Regulatory Consultant

Emergo Global Consulting, LLC
Audrey Swearingen

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
NCT02202538 Completed Interventional Industry-sponsored

Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI).

53
Patients (actual)
5
Sites
Treatment
Purpose
Open label
Masking
Condition studied Spinal Cord Injury
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Parker Hannifin Corporation (industry)
Started 2014-08-01 → Primary completion 2015-10-01
Primary outcome
Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT)
Secondary outcome
Walking Index for Spinal Cord Injury (WISCI-II) Assessment
View full study on ClinicalTrials.gov

Regulatory Peers - PHL Powered Exoskeleton

All 25
Devices cleared under the same product code (PHL) and FDA review panel - the closest regulatory comparables to K171334.
Honda Walking Assist Device
K181294 · Honda Motor Company, Ltd. · Dec 2018
Indego(R)
K173530 · Parker Hannifin Corporation · Jan 2018
HAL for Medical Use (Lower Limb Type)
K171909 · Cyberdyne, Inc. · Dec 2017
ReWalk(TM)
K160987 · Rewalk Robotics, Inc. · Jul 2016
Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
K161443 · Ekso Bionics, Inc. · Jul 2016
Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
K143690 · Ekso Bionics, Inc. · Apr 2016