QZO

Wearable Vibration Device For Orthopedic Use

Product code
QZO
Device name
Wearable Vibration Device For Orthopedic Use
Device class
Class 2
21 CFR
21 CFR 888.5895
Medical specialty
Orthopedic
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-01-12.

NumberDecision dateApplicantDevice nameSummary
DEN2300152024-01-12Bone Health Technologies, Inc.Osteoboost Belt
Official FDA classification page: QZO
Classification and pathway per current FDA publications. Data from openFDA (CC0).