Swiss DolorClast FT-183
by E.M.S. Electro Medical Systems S.A.
Swiss DolorClast FT-183 is a medical device (FDA Class III; FDA product code NBN, Generator, Shock-Wave, For Pain Relief) made by E.M.S. Electro Medical Systems S.A., approved under FDA PMA P050004 on 8 May 2007 and listed in FDA GUDID since 4 Nov 2015 (UDI-DI 07613353000011), active as of 23 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07613353000011 | Date4 Nov 2015 | StatusListed |
| United States | FDA PMAAPPR | NumberP050004 | Date8 May 2007 | StatusActive |
Official records
- AccessGUDID record 07613353000011
- FDA PMA database P050004
Across registries
- FDA PMA P050004 decided 8 May 2007 Active
- FDA GUDID UDI-DI 07613353000011 listed 4 Nov 2015 Listed
Timeline
- Approved FDA PMA P050004
- Listed FDA GUDID 07613353000011
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Swiss DolorClast
- Generic name
- Pneumatic orthopaedic extracorporeal shock wave therapy system
- Model / reference
- FT-183
- Primary DI / UDI-DI
- 07613353000011
- PMA number
- FDA product code
- NBN
- GMDN term
- Pneumatic orthopaedic extracorporeal shock wave therapy system
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code NBN (Generator, Shock-Wave, For Pain Relief).
- Orbasone Pain Relief System by Orthometrix, Inc.
- Orthospec Extracorporeal Shock Wave Therapy Device by Medispec, Ltd.
- Healthtronics Ossatron by Sanuwave, Inc.
- Siemens Sonocur Basic Extracorporeal Shock Wave Therapy System by SIEMENS MEDICAL SOLUTIONS USA, INC.
- Storz Medical Duolith SD1 Shock Wave Therapy by Storz Medical AG
- Dornier EPOS Ultra by Dornier MedTech America, Inc.