510(k) DEN220083
DEN220083 is an FDA 510(k) premarket notification submitted by Swing Therapeutics, Inc. for the device "Stanza". The FDA issued a decision of De Novo Granted on May 9, 2023. The device falls under product code QWI (Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms), a Class II device regulated under 21 CFR 882.5804.
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