Orthospec OR-3-A999u
Orthospec OR-3-A999u is a Class III device made by Medispec, Ltd., approved under FDA PMA P040026 on 1 Apr 2005 and listed in FDA GUDID since 22 Jun 2017 (UDI-DI 07290016498417), 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 | Number07290016498417 | Date22 Jun 2017 | StatusListed |
| United States | FDA PMAAPPR | NumberP040026 | Date1 Apr 2005 | StatusActive |
Official records
- AccessGUDID record 07290016498417
- FDA PMA database P040026
Across registries
- FDA PMA P040026 decided 1 Apr 2005 Active
- FDA GUDID UDI-DI 07290016498417 listed 22 Jun 2017 Listed
Timeline
- Approved FDA PMA P040026
- Listed FDA GUDID 07290016498417
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Orthospec
- Generic name
- Spark-gap orthopaedic extracorporeal shock wave therapy system
- Model / reference
- OR-3-A999u
- Primary DI / UDI-DI
- 07290016498417
- PMA number
- FDA product code
- NBN
- GMDN term
- Spark-gap 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).
- Storz Medical Duolith SD1 Shock Wave Therapy by Storz Medical AG
- Dornier EPOS Ultra by Dornier MedTech America, Inc.
- EMS Swiss Dolorclast by Electro Medical Systems (Ems Sa)
- Orbasone Pain Relief System by Orthometrix, Inc.
- Healthtronics Ossatron by Sanuwave, Inc.
- Siemens Sonocur Basic Extracorporeal Shock Wave Therapy System by SIEMENS MEDICAL SOLUTIONS USA, INC.