OME

Extracorporeal Shock Wave Treatment

Product code: OME
Device name: Extracorporeal Shock Wave Treatment
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification definition

For use for extracorporeal shock wave treatment of atrophic nonunion fractures. The device delivers a shock wave to the patient via a water-filled coupling membrane whic is intented to help atrophic nonunion fractures heal.

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

Official FDA classification page: OME

Classification and pathway per current FDA publications. Data from openFDA (CC0).