510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220083Unknown

Stanza

Swing Therapeutics, Inc., San Francisco CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN220083 is the FDA 510(k) clearance record for Stanza, a class II device, cleared for Swing Therapeutics, Inc. on under FDA product code QWI (Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms). FDA's definition for product code QWI reads: "Provides acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), for patients with fibromyalgia symptoms". FDA records list one 510(k) clearance for Swing Therapeutics, Inc. As of , FDA records show no recalls naming DEN220083.

Clearance record

Decision date
Received
(169 days to decision)
Product code
QWI Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
Regulation
21 CFR 882.5804
Device class
Class II
Review panel
Neurology
Applicant
Swing Therapeutics, Inc. 548 Market St. #63989, San Francisco CA
Third party review
No

Clearances, product code QWI

Trailing 12 months

FDA records hold no clearances under product code QWI in the trailing twelve months.

FDA records show no clearances under product code QWI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QWI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260