510(k) DEN230015
DEN230015 is an FDA 510(k) premarket notification submitted by Bone Health Technologies, Inc. for the device "Osteoboost Belt". The FDA issued a decision of De Novo Granted on January 12, 2024. The device falls under product code QZO (Wearable Vibration Device For Orthopedic Use), a Class II device regulated under 21 CFR 888.5895.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- January 12, 2024
- Date Received
- February 17, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wearable Vibration Device For Orthopedic Use
- Device Class
- Class II
- Regulation Number
- 888.5895
- Review Panel
- OR
- Submission Type
A wearable vibration device for orthopedic use is a wearable device that uses mechanical vibrations, targeted to specific regions of the skeleton, to reduce loss of bone strength or bone mineral density.