QZO
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Wearable Vibration Device For Orthopedic Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.5895
- Medical specialty
- Orthopedic
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Osteoboost Belt (DEN230015) | Bone Health Technologies, Inc. | 2024-01-12 |
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