Not Cleared Direct

DEN210046 - Quell-FM

DEN210046 is an FDA 510(k) submission for Quell-FM, manufactured by Neurometrix, Inc.. The device is a Class 2 Neurology device with product code QSQ cleared through the Direct 510(k) pathway after a 225-day FDA review.

DEN210046 · Neurometrix, Inc. · Neurology device
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May 2022
Decision
225d
Days
Class 2
Risk

DEN210046 is an FDA 510(k) submission (not cleared) for the Quell-FM. Classified as Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms (product code QSQ), Class II - Special Controls.

Submitted by Neurometrix, Inc. (Woburn, US). The FDA issued a Not Cleared (DENG) decision on May 18, 2022 after a review of 225 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5888 - 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 - DEN210046

510(k) Number DEN210046 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 05, 2021
Decision Date May 18, 2022
Days to Decision 225 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 149d · This submission: 225d
Pathway characteristics

QSQ Device Classification - Class 2, Special Controls

Product Code QSQ Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5888
Definition Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms.
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.