510(k) DEN220083
- Device
- Stanza
- Applicant
- Swing Therapeutics, Inc.
- 510(k) number
- DEN220083
- Product code
- QWI
- Decision
- Unknown (DENG)
- Decision date
- 2023-05-09
- Date received
- 2022-11-21
- Regulation
- 882.5804
- Classification name
- Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Michael Rosenbluth
- Address
- 548 Market St. #63989 San Francisco CA US 94104 94104
FDA Registration Numbers
- 3027366657
Source Documents
510(k) summary PDF not indicated by FDA
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860010446362 | Stanza | Swing Therapeutics, Inc. | 2025-09-15 |
| 00860010446355 | Stanza | Swing Therapeutics, Inc. | 2025-09-15 |
| 00860010446324 | Stanza | Swing Therapeutics, Inc. | 2023-07-13 |
| 00860010446317 | Stanza | Swing Therapeutics, Inc. | 2023-07-12 |