NeuroStar Head Support System, Domestic
The NeuroStar Head Support System can be adjusted to the patient's comfort and is used to aid in the process of determining and recording the coil locations during the motor threshold (MT)…
The NeuroStar Head Support System can be adjusted to the patient’s comfort and is used to aid in the process of determining and recording the coil locations during the motor threshold (MT) and treatment processes. NeuroStar Head Support System, Domestic, Demo.
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) | K161519 |
| Record published | 2025-12-09 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 81-04836-00U | In distribution | |
| 81-07836-00U | In distribution | |
| 81-07836-000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MagPro Accessories | Tonica Elektronik A/S | 31 |
| MagPro | Tonica Elektronik A/S | 18 |
| NeuroStar Advanced Therapy System | Neuronetics Inc. | 15 |
| 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 |
| 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.