De Novo DEN230015
- Device
- Osteoboost Belt
- Contact
- laura yecies
- De Novo number
- DEN230015
- Product code
- QZO
- Regulation
- 888.5895
- Classification name
- wearable vibration device for orthopedic use
- Decision
- granted (DENG)
- Decision date
- 2024-01-12
- Date received
- 2023-02-17
- Classification advisory
- Orthopedic
- Review advisory
- Orthopedic
- Type
- Direct
Current FDA Classification#
- Product code
- QZO
- Device name
- Wearable Vibration Device For Orthopedic Use
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation
- 888.5895
- Implant
- N
- Life sustain/support
- N