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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

CountryMakers
United States5
China3
Israel1
Russia1
Denmark1
Bulgaria1
Germany1
Finland1
United Kingdom1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Brainsway Ltd.Jerusalem, IsraelManufacturer2March 8, 2019000api.fda.gov
Neurosoft LtdIvanovo Ivanovskaya Oblast', RussiaManufacturer2December 22, 2023000api.fda.gov
Neuronetics Inc.Malvern, PA, United StatesComplaint file establishment, Manufacturer, Specification developer2June 8, 2023000api.fda.gov
Yiwu Inwell Craft&gift Co.,ltdJin Hua Zhejiang, ChinaManufacturer2June 8, 2023000api.fda.gov
Shenzhen Yingchi Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1April 17, 2025000api.fda.gov
Tonica Elektronik A/SFARUM Hovedstaden, DenmarkManufacturer1August 9, 2020000api.fda.gov
BTL Industries JSCPlovdiv, BulgariaManufacturer0000api.fda.gov
D&K EngineeringSan Diego, CA, United StatesContract manufacturer0000api.fda.gov
Domico Med-Device, LLCFenton, MI, United StatesContract manufacturer0000api.fda.gov
Mag & More GMBHMunich Bavaria, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Mastars Industries Co., LtdGuangdong, ChinaContract manufacturer0000api.fda.gov
Molex LLCNaperville, IL, United StatesContract manufacturer0000api.fda.gov
Nexstim PlcHelsinki Uusimaa, FinlandManufacturer0000api.fda.gov
Spartronics Strongsville, Inc.Strongsville, OH, United StatesContract manufacturer0000api.fda.gov
The Magstim Company Ltd.Carmarthenshire Wales, United KingdomManufacturer0000api.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.