Cleared Traditional

ReWalk Restore

K190337 · Re Walk Robotics , Ltd. · Neurology

Jun 2019

Decision

109d

Days

Class 2

Risk

About This 510(k) Submission

K190337 is an FDA 510(k) clearance for the ReWalk Restore, a Powered Exoskeleton (Class II — Special Controls, product code PHL), submitted by Re Walk Robotics , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on June 3, 2019, 109 days after receiving the submission on February 14, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 890.3480.

Submission Details

510(k) Number	K190337 FDA.gov
FDA Decision	Cleared 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

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.