Skip to contentDe Novo DEN220083
- Device
- Stanza
- Contact
- michael rosenbluth
- De Novo number
- DEN220083
- Product code
- QWI
- Regulation
- 882.5804
- Classification name
- computerized behavioral therapy device for the treatment of fibromyalgia symptoms
- Decision
- granted (DENG)
- Decision date
- 2023-05-09
- Date received
- 2022-11-21
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- QWI
- Device name
- Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.5804
- Implant
- N
- Life sustain/support
- N