Cleared Traditional

Indego(R) (K173530) - FDA 510(k) Clearance

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

K173530 · Parker Hannifin Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
77d
Days
Class 2
Risk

K173530 is an FDA 510(k) clearance for the Indego(R). 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 January 31, 2018 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Parker Hannifin Corporation devices

Submission Details

510(k) Number K173530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2017
Decision Date January 31, 2018
Days to Decision 77 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
71d faster than avg
Panel avg: 148d · This submission: 77d
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

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
NCT03054064 Completed Interventional Industry-sponsored

Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

48
Patients (actual)
7
Sites
Other
Purpose
Open label
Masking
Condition studied Cerebrovascular Accident (CVA); Stroke; Hemiplegia
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Parker Hannifin Corporation (industry)
Started 2017-02-21 → Primary completion 2017-12-28 → Completed 2018-01-17
Primary outcome
Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events
Secondary outcome
Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale
View full study on ClinicalTrials.gov