Wearable Vibration Device For Orthopedic Use
The wearable vibration device for orthopedic use (product code QZO) is a Class 2 Orthopedic device (regulation 888.5895) that uses mechanical vibrations targeted to specific regions of the skeleton to reduce loss of bone strength or bone mineral density. It requires 510(k) clearance. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QZO
- Device Class
- FDA class 2
- Regulation Number
- 888.5895
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN230015 | Osteoboost Belt | Jan 12, 2024 | Unknown | Bone Health Technologies, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.