Product code QZO
- Device name
- Wearable Vibration Device For Orthopedic Use
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.5895
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| DEN230015 | Osteoboost Belt | Bone Health Technologies, Inc. | 2024-01-12 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00860003039724 | Osteoboost | Bone Health Technologies, Inc | 2024-10-12 |
| 00860003039731 | Osteoboost | Bone Health Technologies, Inc | 2024-10-12 |
| 00860003039748 | Osteoboost | Bone Health Technologies, Inc | 2024-10-12 |