Cleared Traditional

EksoNR

K220988 · Ekso Bionics, Inc. · Neurology
Jun 2022
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K220988 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 9, 2022, 66 days after receiving the submission on April 4, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 890.3480.

Submission Details

510(k) Number K220988 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2022
Decision Date June 09, 2022
Days to Decision 66 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.