Cleared Special

K160987 - ReWalk(TM)

K160987 is an FDA 510(k) clearance for ReWalk(TM), manufactured by Rewalk Robotics, Inc.. The device is a Class 2 Neurology device with product code PHL cleared through the Special 510(k) pathway after a 105-day FDA review.

K160987 · Rewalk Robotics, Inc. · Neurology device
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Jul 2016
Decision
105d
Days
Class 2
Risk

K160987 is an FDA 510(k) clearance for the ReWalk(TM). Classified as Powered Exoskeleton (product code PHL), Class II - Special Controls.

Submitted by Rewalk Robotics, Inc. (Marlborough, US). The FDA issued a Cleared decision on July 22, 2016 after a review of 105 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K160987

510(k) Number K160987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2016
Decision Date July 22, 2016
Days to Decision 105 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 149d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

PHL Device Classification - Class 2, Special Controls

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 25
Devices cleared under the same product code (PHL) and FDA review panel - the closest regulatory comparables to K160987.
Indego(R)
K173530 · Parker Hannifin Corporation · Jan 2018
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K171909 · Cyberdyne, Inc. · Dec 2017
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K171334 · Parker Hannifin Corporation · Sep 2017
Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
K161443 · Ekso Bionics, Inc. · Jul 2016
Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
K143690 · Ekso Bionics, Inc. · Apr 2016
Indego
K152416 · Parker Hannifin Corporation · Feb 2016
K160987 · ReWalk(TM)
Download PDF Rewalk Robotics, Inc.