Not Cleared Direct

DEN200050 - Portable Neuromodulation Stimulator (PoNS)

DEN200050 is an FDA 510(k) submission for Portable Neuromodulation Stimulator (..., manufactured by Helius Medical, Inc.. The device is a Class 2 Neurology device with product code QCF cleared through the Direct 510(k) pathway after a 234-day FDA review.

DEN200050 · Helius Medical, Inc. · Neurology device
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Mar 2021
Decision
234d
Days
Class 2
Risk

DEN200050 is an FDA 510(k) submission (not cleared) for the Portable Neuromodulation Stimulator (PoNS). Classified as Electrical Tongue Stimulator To Treat Motor Deficits (product code QCF), Class II - Special Controls.

Submitted by Helius Medical, Inc. (Newton, US). The FDA issued a Not Cleared (DENG) decision on March 26, 2021 after a review of 234 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5889 - 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.

FDA 510(k) Submission Details - DEN200050

510(k) Number DEN200050 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 04, 2020
Decision Date March 26, 2021
Days to Decision 234 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 149d · This submission: 234d
Pathway characteristics

QCF Device Classification - Class 2, Special Controls

Product Code QCF Electrical Tongue Stimulator To Treat Motor Deficits
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5889
Definition An Electrical Tongue Nerve Stimulator To Treat Motor Deficits Is A Prescription Device That Consists Of A Non-implantable Apparatus To Generate Electrical Pulses For Stimulation Of The Nerves In The Tongue To Provide Treatment Of Motor Deficits.
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.

DEN200050 · Portable Neuromodulation Stimulator (PoNS)
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