Cleared Traditional

ReWalk P6.0

K221696 · Re Walk Robotics , Ltd. · Neurology

Mar 2023

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K221696 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 March 2, 2023, 265 days after receiving the submission on June 10, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 890.3480.

Submission Details

510(k) Number	K221696 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 2022
Decision Date	March 02, 2023
Days to Decision	265 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.