Cleared Traditional

K161443 - Ekso™ (version 1.1) and Ekso GT™ (version 1.2) (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161443 · Ekso Bionics, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Jul 2016
Decision
55d
Days
Class 2
Risk

K161443 is an FDA 510(k) clearance for the Ekso™ (version 1.1) and Ekso GT™ (version 1.2). Classified as Powered Exoskeleton (product code PHL), Class II - Special Controls.

Submitted by Ekso Bionics, Inc. (Richmond, US). The FDA issued a Cleared decision on July 19, 2016 after a review of 55 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 Ekso Bionics, Inc. devices

Submission Details

510(k) Number K161443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2016
Decision Date July 19, 2016
Days to Decision 55 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
93d faster than avg
Panel avg: 148d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Regulatory Peers - PHL Powered Exoskeleton

All 23
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