Not Cleared Direct

DEN220059 - NTX100 Tonic Motor Activation (NTX100 ToMAc) System (FDA 510(k) Clearance)

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

DEN220059 · Noctrix Health, Inc. · Neurology device
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Apr 2023
Decision
208d
Days
Class 2
Risk

DEN220059 is an FDA 510(k) submission (not cleared) for the NTX100 Tonic Motor Activation (NTX100 ToMAc) System. Classified as Stimulator, Nerve, For Restless Legs Syndrome (product code QWD), Class II - Special Controls.

Submitted by Noctrix Health, Inc. (Pleasanton, US). The FDA issued a Not Cleared (DENG) decision on April 17, 2023 after a review of 208 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5887 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Neurology review framework.

View all Noctrix Health, Inc. devices

Submission Details

510(k) Number DEN220059 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 21, 2022
Decision Date April 17, 2023
Days to Decision 208 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 148d · This submission: 208d
Pathway characteristics

Device Classification

Product Code QWD Stimulator, Nerve, For Restless Legs Syndrome
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5887
Definition An External Lower Extremity Nerve Stimulator For Restless Legs Syndrome Is A Prescription Device That Uses External Electrical Stimulators And Cutaneous Electrodes To Stimulate Nerves In The Lower Extremity (e.g.,peroneal Nerves) And Evoke Tonic, Sustained Muscle Activation In The Legs To Reduce The Symptoms Of Restless Legs Syndrome.
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.