Product code QZO

Device name

Wearable Vibration Device For Orthopedic Use

Medical specialty

Orthopedic

Device class

2

Regulation number

888.5895

Review panel

OR

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset