Not Cleared Direct

DEN220083 - Stanza (FDA 510(k) Clearance)

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

DEN220083 · Swing Therapeutics, Inc. · Neurology device
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May 2023
Decision
169d
Days
Class 2
Risk

DEN220083 is an FDA 510(k) submission (not cleared) for the Stanza. Classified as Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms (product code QWI), Class II - Special Controls.

Submitted by Swing Therapeutics, Inc. (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on May 9, 2023 after a review of 169 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5804 - 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 Swing Therapeutics, Inc. devices

Submission Details

510(k) Number DEN220083 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 21, 2022
Decision Date May 09, 2023
Days to Decision 169 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 148d · This submission: 169d
Pathway characteristics

Device Classification

Product Code QWI Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5804
Definition Provides Acceptance And Commitment Therapy (act), A Form Of Cognitive Behavioral Therapy (cbt), For Patients With 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.