510(k) K143531 ยท OBP Transcranial Magnetic Stimulator
Rapid Therapy System
| Applicant | Magstim Company Limited, Carmarthenshire, GB |
| Decision | Substantially Equivalent, May 8, 2015 |
| Received | Dec 12, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143531
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2020 | The Magstim Company Limited Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from p Terminated |
OBP | None listed |
| Mar 23, 2020 | The Magstim Company Limited Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antid Terminated |
OBP | None listed |
| Sep 28, 2017 | The Magstim Company Limited Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters
Product Usage For the treatment of major depressive Terminated |
OBP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.