Not Cleared Direct

DEN130034 - REWALK (FDA 510(k) Clearance)

Class II Neurology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN130034 · Argo Medical Technologies, Inc. · Neurology device
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Jun 2014
Decision
374d
Days
Class 2
Risk

DEN130034 is an FDA 510(k) submission (not cleared) for the REWALK. Classified as Powered Exoskeleton (product code PHL), Class II - Special Controls.

Submitted by Argo Medical Technologies, Inc. (Marlborough, US). The FDA issued a Not Cleared (DENG) decision on June 26, 2014 after a review of 374 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.3480 - the FDA neurology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 374 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Argo Medical Technologies, Inc. devices

Submission Details

510(k) Number DEN130034 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 17, 2013
Decision Date June 26, 2014
Days to Decision 374 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 148d · This submission: 374d
Pathway characteristics

Device Classification

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.