Cleared Traditional

ReWalk Restore (K190337) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence.

K190337 · Re Walk Robotics , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
109d
Days
Class 2
Risk

K190337 is an FDA 510(k) clearance for the ReWalk Restore. Classified as Powered Exoskeleton (product code PHL), Class II - Special Controls.

Submitted by Re Walk Robotics , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on June 3, 2019 after a review of 109 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 Re Walk Robotics , Ltd. devices

Submission Details

510(k) Number K190337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2019
Decision Date June 03, 2019
Days to Decision 109 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
39d faster than avg
Panel avg: 148d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03499210 Unknown Interventional Industry-sponsored

Safety Evaluation of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Stroke

A Multi-site, Interventional, Non-comparative, Single-arm Trial to Evaluate the Safety of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Ischemic or Hemorrhagic Stroke

40
Patients (est.)
5
Sites
Other
Purpose
Open label
Masking
Condition studied Stroke; Stroke, Acute; Stroke Hemorrhagic; Hemiparesis; Hemiplegia; Cerebrovascular Accident
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor ReWalk Robotics, Inc. (industry)
Started 2018-03-29 → Primary completion 2018-11-30
Primary outcome
Incidence of device-related adverse events [Safety]
Secondary outcome
Incidence of device malfunctions during study procedures [Device Reliability]
View full study on ClinicalTrials.gov

Regulatory Peers - PHL Powered Exoskeleton

All 16
Devices cleared under the same product code (PHL) and FDA review panel - the closest regulatory comparables to K190337.
Keeogo Dermoskeleton System
K201539 · B-Temia, Inc. · Sep 2020
EksoNR
K200574 · Ekso Bionics, Inc. · Jun 2020
ReWalk P6.0
K200032 · Re Walk Robotics , Ltd. · May 2020
Phoenix
K183152 · Us Bionics, Inc. (Dba Suitx) · Apr 2019
Honda Walking Assist Device
K181294 · Honda Motor Company, Ltd. · Dec 2018
Indego(R)
K173530 · Parker Hannifin Corporation · Jan 2018