DeviceClearance

Product code QZO— Orthopedic

Osteoboost Belt

Classification name
Wearable Vibration Device For Orthopedic Use
Device class
Class 2
Regulation
21 CFR 888.5895
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QZO under 21 CFR 888.5895, via openFDA

Market context for product code QZO

FDA has cleared 1 device under product code QZO, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QZO

Recent clearances under product code QZO

Data sourced from openFDA. This site is unofficial and independent of the FDA.