OME — Extracorporeal Shock Wave Treatment Class III
FDA product code OME covers "Extracorporeal Shock Wave Treatment", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OME
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Unknown
- Implant
- No
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.