Cleared Traditional

K161443 - Ekso™ (version 1.1) and Ekso GT™ (version 1.2)

K161443 is an FDA 510(k) clearance for Ekso (version 1.1) and Ekso GT (version..., manufactured by Ekso Bionics, Inc.. The device is a Class 2 Neurology device with product code PHL cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K161443 · Ekso Bionics, Inc. · Neurology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K161443

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 149d · This submission: 55d
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.

Regulatory Consultant

Hogan Lovells US LLP
John J. Smith

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.

Regulatory Peers - PHL Powered Exoskeleton

All 25
Devices cleared under the same product code (PHL) and FDA review panel - the closest regulatory comparables to K161443.
HAL for Medical Use (Lower Limb Type)
K171909 · Cyberdyne, Inc. · Dec 2017
Indego
K171334 · Parker Hannifin Corporation · Sep 2017
ReWalk(TM)
K160987 · Rewalk Robotics, Inc. · Jul 2016
Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
K143690 · Ekso Bionics, Inc. · Apr 2016
Indego
K152416 · Parker Hannifin Corporation · Feb 2016
REWALK
DEN130034 · Argo Medical Technologies, Inc. · Jun 2014