QZO
- Product code
- QZO
- Device name
- Wearable Vibration Device For Orthopedic Use
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.5895
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
FDA classification 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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| DEN230015 | 2024-01-12 | Bone Health Technologies, Inc. | Osteoboost Belt | — |
Official FDA classification page: QZO
Classification and pathway per current FDA publications. Data from openFDA (CC0).