Nexstim PLC
Country not established FDA FEI 3007147067
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 20 ongoing since 2021 (2 open in total)
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Nexstim PLC makes
Nexstim Plc manufactures the Navigated Brain Therapy (NBT) System 2, a device designed for non-invasive brain stimulation and neuromodulation therapies. This system integrates electrical stimulation with neuroimaging to guide precise treatment targeting for neurological and psychiatric conditions. It is used in clinical settings for applications such as transcranial direct current stimulation (tDCS) and related neuromodulation protocols.
The NBT System 2 is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) database. The company is based in the United States, where its devices are authorised for commercial distribution.
Catalogue
Nexstim Navigated Brain Therapy (NBT) System 2 Ref K171902
Regimes: CE MDD 510(k) Registry: 510(k)Nexstim Navigated Brain Therapy (NBT) System 2 Ref K182700
Regimes: CE MDD 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3007147067
- Address
- Elimaenkatu 9B, Helsinki Uusimaa
FDA recalls
FDA recall records list 2 recalls initiated by Nexstim Plc, initiated on 2017-03-14. By recorded status: 2 ongoing. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 2
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 14 Mar 2017 Z-2319-2017 Class II Open since 2017 Software defect: the NBS software may accidentally generate duplicate copies of one or several files.
- 14 Mar 2017 Z-2320-2017 Class II Open since 2017 Software defect: the NBS software may accidentally generate duplicate copies of one or several files.
Frequently asked questions
How many devices does Nexstim Plc have in the registry?
The registry currently lists 2 devices for Nexstim Plc. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nexstim Plc's devices?
Among its 2 most recently registered devices, Nexstim Plc has devices listed in FDA 510(k) (2 devices).
What risk classes do Nexstim Plc's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Nexstim Plc's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Nexstim Plc?
FDA recall records list 2 recalls initiated by Nexstim Plc, the most recent initiated on 14 Mar 2017. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Nexstim Plc in the registry?
The most recently registered devices listed for Nexstim Plc include Nexstim Navigated Brain Therapy (NBT) System 2.