

# NBN · Generator, Shock-Wave, For Pain Relief

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/NBN

## Overview

- **Product Code:** NBN
- **Device Name:** Generator, Shock-Wave, For Pain Relief
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P080028](/device/P080028.md) | STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY | Storz Medical AG | Jan 8, 2016 | APPR |
| [P050004](/device/P050004.md) | EMS SWISS DOLORCLAST | Electro Medical Systems (Ems Sa) | May 8, 2007 | APPR |
| [P040039](/device/P040039.md) | ORBASONE PAIN RELIEF SYSTEM | Orthometrix, Inc. | Aug 10, 2005 | APWD |
| [P040026](/device/P040026.md) | ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE | Medispec, Ltd. | Apr 1, 2005 | APPR |
| [P010039](/device/P010039.md) | SIEMENS SONOCUR BASIC SYSTEM | Siemens Medical Solutions USA, Inc. | Jul 19, 2002 | APWD |
| [P000048](/device/P000048.md) | DORNIER EPOS ULTRA | Dornier Medtech America, Inc. | Jan 15, 2002 | APWD |
| [P990086](/device/P990086.md) | HEALTHTRONICS OSSATRON | Sanuwave, Inc. | Oct 12, 2000 | APWD |

## Top Applicants

- Dornier Medtech America, Inc. — 1 clearance
- Electro Medical Systems (Ems Sa) — 1 clearance
- Medispec, Ltd. — 1 clearance
- Orthometrix, Inc. — 1 clearance
- Sanuwave, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/NBN](https://fda.innolitics.com/productcode/NBN)

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