Not Cleared Direct

DEN200046 - Neurolutions Upper Extremity Rehabilitation System (FDA 510(k) Clearance)

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

DEN200046 · Neurolutions, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
274d
Days
Class 2
Risk

DEN200046 is an FDA 510(k) submission (not cleared) for the Neurolutions Upper Extremity Rehabilitation System. Classified as Electroencephalography (eeg)-driven Upper Extremity Powered Exerciser (product code QOL), Class II - Special Controls.

Submitted by Neurolutions, Inc. (Santa Cruz, US). The FDA issued a Not Cleared (DENG) decision on April 23, 2021 after a review of 274 days.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5420 - the FDA physical medicine 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. Elevated predicate reliance profile. With 274 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 Neurolutions, Inc. devices

Submission Details

510(k) Number DEN200046 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 23, 2020
Decision Date April 23, 2021
Days to Decision 274 days
Submission Type Direct
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 115d · This submission: 274d
Pathway characteristics

Device Classification

Product Code QOL Electroencephalography (eeg)-driven Upper Extremity Powered Exerciser
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5420
Definition An Eeg-driven Upper Extremity Powered Exerciser Is A Non-invasive Prescription Device Intended For Rehabilitation By Driving Movement Or Exercise Of An Impaired Upper Extremity In Response To The Detection Of Purpose Oriented Electrical Activity Produced By The Patient's Brain.
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 Physical Medicine devices follow this clearance model.