21 CFR 888.5895 — Wearable Vibration Device For Orthopedic Use
Orthopedic (OR) · Part 888 Subpart E—Surgical Devices · § 888.5895
Identification
The Osteoboost Belt is a wearable vibration device for orthopedic use, consisting of a vibration pack mounted to a nylon-covered neoprene belt. It is designed to transmit low-amplitude, high-frequency (20-40 Hz) mechanical vibrations to the spine and hips. It is indicated to reduce the decline in bone strength and volumetric bone density, as assessed via CT scans analyzed using the O.N. Diagnostics VirtuOst estimate, 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.
Classification Rationale
Class II (special controls). The device is granted under De Novo classification (21 CFR 888.5895) as a wearable vibration device for orthopedic use, with risks mitigated by general and special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QZO | Wearable Vibration Device For Orthopedic Use | 2 | 1 | SaMD |
Special Controls
QZO — Wearable Vibration Device For Orthopedic Use
In combination with the general controls of the FD&C Act, the wearable vibration device for orthopedic use is subject to the following special controls:
De Novo Order DEN230015
