# OME · Extracorporeal Shock Wave Treatment

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/OR-misc/OME

## Overview

- **Product Code:** OME
- **Device Name:** Extracorporeal Shock Wave Treatment
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/OR/OR-misc/OME](https://fda.innolitics.com/submissions/OR/OR-misc/OME)

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