FDA product code OME: Extracorporeal Shock Wave Treatment
OME is the FDA product code for extracorporeal shock wave treatment. It is a Class III device, reviewed by the Orthopedic panel. Devices under OME reach the market by PMA; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Extracorporeal Shock Wave Treatment |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for OME devices
openFDA lists no recalls for product code OME.
Frequently asked questions
What is FDA product code OME?
OME is the FDA product code for extracorporeal shock wave treatment. It is a Class III device, reviewed by the Orthopedic panel.
What device class is OME?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OME
- Run a recall and safety report across every OME manufacturer
- Watch product code OME for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.