Cleared Traditional

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

K143690 · Ekso Bionics, Inc. · Neurology
Apr 2016
Decision
464d
Days
Class 2
Risk

About This 510(k) Submission

K143690 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 April 1, 2016, 464 days after receiving the submission on December 24, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 890.3480.

Submission Details

510(k) Number K143690 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 2014
Decision Date April 01, 2016
Days to Decision 464 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.