QZO · Class II · 21 CFR 888.5895

FDA Product Code QZO: Wearable Vibration Device For Orthopedic Use

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.

Leading manufacturers include Bone Health Technologies, Inc..

1
Total
0
Cleared
329d
Avg days
2024
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Wearable Vibration Device For Orthopedic Use Devices (Product Code QZO)

1 devices
1–1 of 1

About Product Code QZO - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QZO since 2024, with 0 receiving FDA clearance (average review time: 329 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QZO devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →