Cleared Traditional

EksoNR

K200574 · Ekso Bionics, Inc. · Neurology
Jun 2020
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K200574 is an FDA 510(k) clearance for the EksoNR, a Powered Exoskeleton (Class II — Special Controls, product code PHL), submitted by Ekso Bionics, Inc. (Richmond, US). The FDA issued a Cleared decision on June 19, 2020, 106 days after receiving the submission on March 5, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 890.3480.

Submission Details

510(k) Number K200574 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2020
Decision Date June 19, 2020
Days to Decision 106 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.