Data / Medical devices / Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder (QCI): 15 FDA-registered makers in 9 countries
15 establishments in 9 countries are registered with the FDA to make Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder (product code QCI, Class 2, 21 CFR 882.5802). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on April 17, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QCI
- Device class
- 2
- Regulation
- 882.5802
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 3 |
| Israel | 1 |
| Russia | 1 |
| Denmark | 1 |
| Bulgaria | 1 |
| Germany | 1 |
| Finland | 1 |
| United Kingdom | 1 |
Makers of Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Brainsway Ltd. | Jerusalem, Israel | Manufacturer | 2 | March 8, 2019 | 0 | 0 | 0 | api.fda.gov |
| Neurosoft Ltd | Ivanovo Ivanovskaya Oblast', Russia | Manufacturer | 2 | December 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Neuronetics Inc. | Malvern, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | June 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| Yiwu Inwell Craft&gift Co.,ltd | Jin Hua Zhejiang, China | Manufacturer | 2 | June 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Yingchi Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | April 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Tonica Elektronik A/S | FARUM Hovedstaden, Denmark | Manufacturer | 1 | August 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| BTL Industries JSC | Plovdiv, Bulgaria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| D&K Engineering | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Domico Med-Device, LLC | Fenton, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mag & More GMBH | Munich Bavaria, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mastars Industries Co., Ltd | Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Molex LLC | Naperville, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nexstim Plc | Helsinki Uusimaa, Finland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spartronics Strongsville, Inc. | Strongsville, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Magstim Company Ltd. | Carmarthenshire Wales, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.