Transcranial Magnetic Stimulator
Regulation 882.5805
9510(k)s in 12 months (69 all time)
1recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in OBP
| Company | 510(k)s | Recalls |
|---|---|---|
| Magstim Company Limited | 12 | 4 |
| Neuronetics | 13 | 2 |
| Tonica Elektronik A/S | 10 | 0 |
| Brainsway , Ltd. | 8 | 0 |
| Mag & More GmbH | 5 | 0 |
| Brain Ultimate, Inc. | 3 | 0 |
| Teleemg, LLC | 3 | 0 |
| BTL Industries, Inc. | 2 | 0 |
| Neuromodulatory Devices & Applications | 2 | 0 |
| Nexstim Plc | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2026 | Neuronetics, Inc. NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems:
1. NeuroStar 2.0 US; Part Number: 81-01315-0 Open, Classified |
OBP | K231926 K233621 |
| 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 | K051864 K143531 +4 |
| 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 | K051864 K143531 +4 |
| Oct 25, 2018 | The Magstim Company Limited HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.) Open, Classified |
OBP | K180907 |
| 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 | K143531 K162935 |
| May 27, 2009 | Neuronetics, Inc. NeuroStar TMS Therapy System/SenStar Treatment Link.
The SenStar Treatment Link is a single use, disposable component of the NeuroStar TMS system, a non-invasive treatment for depression using highly Terminated |
OBP | K083538 |
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