Cleared Traditional

EksoNR (K200574) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200574 · Ekso Bionics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
106d
Days
Class 2
Risk

K200574 is an FDA 510(k) clearance for the EksoNR. 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 June 19, 2020 after a review of 106 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ekso Bionics, Inc. devices

Submission Details

510(k) Number K200574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 148d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - PHL Powered Exoskeleton

All 16
Devices cleared under the same product code (PHL) and FDA review panel - the closest regulatory comparables to K200574.
ExoAtlet-II
K201473 · Exoatlet Asia Co. , Ltd. · Jul 2021
HAL for Medical Use(Lower Limb type)
K201559 · Cyberdyne, Inc. · Oct 2020
Keeogo Dermoskeleton System
K201539 · B-Temia, Inc. · Sep 2020
ReWalk P6.0
K200032 · Re Walk Robotics , Ltd. · May 2020
ReWalk Restore
K190337 · Re Walk Robotics , Ltd. · Jun 2019
Phoenix
K183152 · Us Bionics, Inc. (Dba Suitx) · Apr 2019