QZO — Wearable Vibration Device For Orthopedic Use Class II

FDA Device Classification

Classification Details

Product Code
QZO
Device Class
Class II
Regulation Number
888.5895
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN230015bone health technologiesOsteoboost BeltJanuary 12, 2024