FDA product code QZO: Wearable Vibration Device For Orthopedic Use
QZO is the FDA product code for wearable vibration device for orthopedic use. It is a Class II device, regulated under 21 CFR 888.5895 and reviewed by the Orthopedic panel. Devices under QZO reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Wearable Vibration Device For Orthopedic Use |
| Device class | Class II |
| Regulation | 21 CFR 888.5895 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
Recalls for QZO devices
openFDA lists no recalls for product code QZO.
Frequently asked questions
What is FDA product code QZO?
QZO is the FDA product code for wearable vibration device for orthopedic use. It is a Class II device, regulated under 21 CFR 888.5895 and reviewed by the Orthopedic panel.
What device class is QZO?
Class II, regulation 21 CFR 888.5895. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QZO
- Run a recall and safety report across every QZO manufacturer
- Watch product code QZO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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