Cleared Traditional

ReWalk P6.0

K200032 · Re Walk Robotics , Ltd. · Neurology
May 2020
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K200032 is an FDA 510(k) clearance for the ReWalk P6.0, 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 May 26, 2020, 140 days after receiving the submission on January 7, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 890.3480.

Submission Details

510(k) Number K200032 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2020
Decision Date May 26, 2020
Days to Decision 140 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.