Data / Medical devices / Wearable Vibration Device For Orthopedic Use
Wearable Vibration Device For Orthopedic Use (QZO): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Wearable Vibration Device For Orthopedic Use (product code QZO, Class 2, 21 CFR 888.5895). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on January 12, 2024, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QZO
- Device class
- 2
- Regulation
- 888.5895
- Medical specialty
- Orthopedic
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Taiwan | 1 |
Makers of Wearable Vibration Device For Orthopedic Use
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bone Health Technologies | Redwood City, CA, United States | Complaint file establishment, Remanufacturer, Specification developer | 1 | January 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ascentron, Inc. | White City, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wistron Medical Technology Corporation | Zhubei City Hsinchu(County), Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.