Product code NBN
- Device name
- Generator, Shock-Wave, For Pain Relief
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P080028S001 | Storz Medical Duolith SD1 Shock Wave Therapy Device | Storz Medical AG | 2020-02-05 |
| P080028 | STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY | Storz Medical AG | 2016-01-08 |
| P050004S001 | EMS-SWISS DOLORCLAST | Electro Medical Systems (Ems Sa) | 2009-08-28 |
| P050004 | EMS SWISS DOLORCLAST | Electro Medical Systems (Ems Sa) | 2007-05-08 |
| P010039S003 | SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) | Siemens Medical Solutions USA, Inc. | 2005-09-27 |
| P040039 | ORBASONE PAIN RELIEF SYSTEM | Orthometrix, Inc. | 2005-08-10 |
| P040026 | ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE | Medispec, Ltd. | 2005-04-01 |
| P990086S004 | HEALTHTRONICS OSSATRON | Sanuwave, Inc. | 2004-08-06 |
| P010039S002 | SIEMENS SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) SYSTEM | Siemens Medical Solutions USA, Inc. | 2003-04-03 |
| P990086S003 | HEALTHTRONICS OSSATRON | Sanuwave, Inc. | 2003-03-14 |
| P010039 | SIEMENS SONOCUR BASIC SYSTEM | Siemens Medical Solutions USA, Inc. | 2002-07-19 |
| P000048 | DORNIER EPOS ULTRA | Dornier Medtech America, Inc. | 2002-01-15 |
| P990086S001 | HEALTHTRONICS OSSATRON | Sanuwave, Inc. | 2001-05-01 |
| P990086S002 | HEALTHTRONICS OSSATRON | Sanuwave, Inc. | 2001-03-30 |
| P990086 | HEALTHTRONICS OSSATRON | Sanuwave, Inc. | 2000-10-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07630039101404 | DUOLITH® | Storz Medical AG | 2021-06-29 |
| 04260153472031 | Swiss DolorClast | E.M.S. Electro Medical Systems S.A. | 2021-06-02 |
| 07630039101398 | DUOLITH® | Storz Medical AG | 2021-04-08 |
| 07613353194895 | SWISS DOLORCLAST | E.M.S. Electro Medical Systems S.A. | 2020-08-25 |
| 07613353170264 | Swiss DolorClast | E.M.S. Electro Medical Systems S.A. | 2020-06-03 |
| 07630039101312 | CHATTANOOGA | Storz Medical AG | 2020-03-23 |
| 07630039101329 | DUOLITH® | Storz Medical AG | 2020-03-23 |
| 07630039101336 | DUOLITH® | Storz Medical AG | 2020-03-23 |
| 07613353181284 | Swiss DolorClast | E.M.S. Electro Medical Systems S.A. | 2019-10-16 |
| 07613353077464 | Swiss DolorClast | E.M.S. Electro Medical Systems S.A. | 2018-06-22 |
| 07630039101022 | CHATTANOOGA | Storz Medical AG | 2018-05-28 |
| 07290016498417 | Orthospec | MEDISPEC LTD. | 2017-06-22 |
| 07630039100827 | CHATTANOOGA | Storz Medical AG | 2017-01-16 |
| 07630039100759 | CHATTANOOGA | Storz Medical AG | 2016-06-27 |
| 07630039100773 | DUOLITH® | Storz Medical AG | 2016-06-27 |
| 07613353000028 | Swiss DolorClast | E.M.S. Electro Medical Systems S.A. | 2015-11-04 |
| 07613353000042 | Swiss DolorClast | E.M.S. Electro Medical Systems S.A. | 2015-11-04 |
| 07613353000059 | Swiss DolorClast | E.M.S. Electro Medical Systems S.A. | 2015-11-04 |
| 07613353000066 | Swiss DolorClast | E.M.S. Electro Medical Systems S.A. | 2015-11-04 |
| 07613353000011 | Swiss DolorClast | E.M.S. Electro Medical Systems S.A. | 2015-11-04 |
| 07613353000035 | Swiss DolorClast | E.M.S. Electro Medical Systems S.A. | 2015-10-26 |