510(k) DEN230015
- Device
- Osteoboost Belt
- Applicant
- Bone Health Technologies, Inc.
- 510(k) number
- DEN230015
- Product code
- QZO
- Decision
- Unknown (DENG)
- Decision date
- 2024-01-12
- Date received
- 2023-02-17
- Regulation
- 888.5895
- Classification name
- Wearable Vibration Device For Orthopedic Use
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Laura Yecies
- Address
- 370 Convention Way Suite 218 Redwood City CA US 94063 94063
FDA Registration Numbers#
- 3013069546
- 3016783785
Source Documents#
510(k) summary PDF not indicated by FDA