De Novo · Granted
GrantedOsteoboost Belt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bone Health Technologies, Inc. · QZO Wearable Vibration Device For Orthopedic Use
Granted on Jan 12, 2024 as a new device type through De Novo after a 329-day review.
- Decided
- Jan 12, 2024
- Review
- 329 days
- Class
- Class II
- Product code
- QZO
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QZO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QZO devicesQZO Wearable Vibration Device For Orthopedic Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QZO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QZO
Too few QZO 510(k)s in any year since 2007 to give a median.
Recalls per year · QZO
No recall names QZO since 2007.
Adverse event reports per year · QZO
No MAUDE report names QZO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Osteoboost Belt is indicated to reduce the decline in bone strength and volumetric bone density, as assessed via CT (computed tomography) scans that were analyzed using the O.N. Diagnostics VirtuOst estimate of vertebral bone strength and density in postmenopausal women with osteopenia of the lumbar vertebrae or total hip as diagnosed via dual x-ray absorptiometry with a bone mineral density T-score between -1.0 and -2.49. • The clinical effects have…
Read the full statement (135 words)
The Osteoboost Belt is indicated to reduce the decline in bone strength and volumetric bone density, as assessed via CT (computed tomography) scans that were analyzed using the O.N. Diagnostics VirtuOst estimate of vertebral bone strength and density in postmenopausal women with osteopenia of the lumbar vertebrae or total hip as diagnosed via dual x-ray absorptiometry with a bone mineral density T-score between -1.0 and -2.49.
• The clinical effects have only been observed for the duration of the clinical study performed to support the indications for use (1 year).
• Fracture risk was not evaluated in the clinical study to support the indications for use, so it is not known how the treatment effects correlate with fracture risk.
• The clinical effects have been demonstrated only for those who used the device as indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230015 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230015: Osteoboost Belt.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230015
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026