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510(k) DEN220083

Stanza by Swing Therapeutics, Inc. — Product Code QWI

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: May 9, 2023
Date Received: November 21, 2022
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
Device Class: Class II
Regulation Number: 882.5804
Review Panel: PM
Submission Type

Provides acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), for patients with fibromyalgia symptoms