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
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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
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 148d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.