# DEN230015: Osteoboost Belt

- Pathway: De Novo (Direct)
- Applicant: Bone Health Technologies, Inc.
- Decided: Jan 12, 2024 after 329 days
- Product code: QZO (Wearable Vibration Device For Orthopedic Use)
- Device class: 2
- Regulation: 21 CFR 888.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
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.

Source page: https://510kreport.com/device/DEN230015
Methodology: https://510kreport.com/methodology