510(k) DEN230015

Osteoboost Belt by Bone Health Technologies, Inc. — Product Code QZO

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: January 12, 2024
Date Received: February 17, 2023
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Wearable Vibration Device For Orthopedic Use
Device Class: Class II
Regulation Number: 888.5895
Review Panel: OR
Submission Type

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.