Cleared Traditional

Ekso? (version 1.1) and Ekso GT? (version 1.2)

K161443 · Ekso Bionics, Inc. · Neurology

Jul 2016

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K161443 is an FDA 510(k) clearance for the Ekso? (version 1.1) and Ekso GT? (version 1.2), a Powered Exoskeleton (Class II — Special Controls, product code PHL), submitted by Ekso Bionics, Inc. (Richmond, US). The FDA issued a Cleared decision on July 19, 2016, 55 days after receiving the submission on May 25, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 890.3480.

Submission Details

510(k) Number	K161443 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	PHL — Powered Exoskeleton
Device Class	Class II — 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.