DEN230015 is an FDA 510(k) submission for the Osteoboost Belt. This device is classified as a Wearable Vibration Device For Orthopedic Use (Class II - Special Controls, product code QZO).
Submitted by Bone Health Technologies, Inc. (Redwood City, US). The FDA issued a Not Cleared (DENG) decision on January 12, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.5895. 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..
| 510(k) Number | DEN230015 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 17, 2023 |
| Decision Date | January 12, 2024 |
| Days to Decision | 329 days |
| Submission Type | Direct |
| Review Panel | Orthopedic (OR) |
| Summary | - |
| Product Code | QZO - Wearable Vibration Device For Orthopedic Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.5895 |
| 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. |