NeuroSITE
The NeuroSITE is used to aid in the process of determining and recording the coil locations during the motor threshold (MT) and treatment processes.
3manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
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 | QCI |
| Device type | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5802 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K233621 |
| Record published | 2024-01-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date |
| Packaging | Inner pack of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 81-72024-000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Deep Transcranial Magnetic Stimulation (Dtms) System | Brainsway Ltd. | 6 |
| MagPro Accessories | Tonica Elektronik A/S | 5 |
| CloudTMS for OCD | Neurosoft, OOO | 3 |
| TrakStar Patient Data Management System Software | Neuronetics Inc. | 2 |
| CloudTMS Edge for OCD | Neurosoft, OOO | 2 |
| NeuroStar Headrest | Neuronetics Inc. | 2 |
| CoudTMS Edge for OCD | Neurosoft, OOO | 1 |
| SenStar Connect Treatment Link | Neuronetics Inc. | 1 |
| OCD MT Cap | Neuronetics Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231350 | 2023-06-08 |
| K212289 | 2022-05-06 |
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.