NeuroStar Advanced Therapy System
The NeuroStar 3.X to 3.7 upgrade kit updates compatible NeuroStar Advanced Therapy systems to software version 3.7. This specific kit is for systems that are not TouchStar capable, a…
The NeuroStar 3.X to 3.7 upgrade kit updates compatible NeuroStar Advanced Therapy systems to software version 3.7. This specific kit is for systems that are not TouchStar capable, a distinction that separates it from a separate TouchStar-capable upgrade listing.
The kit is a system upgrade component, not a complete NeuroStar treatment system. Its documented scope here is the software-version transition and compatible system grouping.
Listed Item
3.X to 3.7 System Upgrade Kit for NeuroStar systems that are not TouchStar Capable
Upgrade Scope
The filed version transition is from 3.X to 3.7. The non-TouchStar designation specifies which NeuroStar systems this kit is intended to upgrade.
The upgrade is associated with the NeuroStar Advanced Therapy platform. The source identifies the version and compatibility group but does not enumerate individual feature changes.
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mastars Industries Co., Ltd. | Guangdong | Guangdong | Contract manufacturer | 3 |
| Yiwu Inwell Craft&Gift Co., Ltd. | Jin Hua | Zhejiang | Contract manufacturer | 7 |
| Shenzhen Yingchi Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Neuronetics Inc., United States |
|---|---|
| FDA product code | OBP |
| Device type | Transcranial Magnetic Stimulator |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5805 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K201158 |
| Record published | 2022-09-30 |
| Record revised | 2023-07-07 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3.X to 3.7 System Upgrade Kit (without TouchStar) | In distribution | |
| Version 3.8 | In distribution | |
| Version 3.7 | In distribution | |
| Version 3.6 | In distribution | |
| Version 3.6 | In distribution | |
| 3.X to 3.7 System Upgrade Kit (TouchStar Capable) | In distribution | |
| Version 3.7 | In distribution | |
| Version 3.8 | In distribution | |
| Version 3.6 | In distribution | |
| Version 3.8 | In distribution | |
| 2.X to 3.7 System Upgrade Kit | In distribution | |
| Version 3.X | In distribution | |
| Version 3.7 | In distribution | |
| 3.X | In distribution | |
| 2.X | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MagPro Accessories | Tonica Elektronik A/S | 31 |
| MagPro | Tonica Elektronik A/S | 18 |
| Deep Transcranial Magnetic Stimulation (Dtms) System | Brainsway Ltd. | 10 |
| TrakStar Patient Data Management System Software | Neuronetics Inc. | 5 |
| NeuroStar System Software | Neuronetics Inc. | 4 |
| NeuroStar TMS Therapy System | Neuronetics Inc. | 4 |
| Ultimate rTMS | Shenzhen Yingzhi Technology Co., Ltd. | 4 |
| NeuroStar Head Support System, Domestic | Neuronetics Inc. | 3 |
| Saint | Magnus Medical Inc. | 3 |
| SenStar Treatment Link | Neuronetics Inc. | 2 |
| Ampa One System | Neuromodulatory Devices & Applications | 2 |
| TMS Coil Cooler | Shenzhen Yingzhi Technology Co., Ltd. | 2 |
Showing 12 of 98. All products under Transcranial Magnetic Stimulator
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231926 | 2024-03-22 |
| K233621 | 2023-12-13 |
| K230029 | 2023-04-04 |
| K222230 | 2022-08-24 |
| K220127 | 2022-07-15 |
| K213543 | 2021-12-10 |
| K201158 | 2020-11-20 |
| K161519 | 2016-09-11 |
| K160703 | 2016-06-10 |
| K133408 | 2014-03-28 |
| K130233 | 2013-04-30 |
| K083538 | 2008-12-16 |
| DEN070003 | 2008-10-07 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-03-16 | Not classified | Process control | SenStar Treatment Link may have an open circuit that during use with the NeuroStar TMS Therapy system may cause arcing and heat damage to the SenStar and/or treatment coil. Heating of the SenStar during use has a potential risk of minor sc | 3123 Units | 2009-05-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.