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.

View all Rewalk Robotics, Inc. devices

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
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 148d · 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.