Deep Transcranial Magnetic Stimulation (Dtms) System
Upgrade kit – arm with H7 coil for 104 system
3manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
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 | Brainsway Ltd., Israel |
|---|---|
| FDA product code | QCI |
| Device type | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5802 |
| Establishment | Manufacturer |
| 510(k) | K183303 |
| Record published | 2026-05-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 85 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
| Sizes | Weight 43.2 to 161 kg; height 100 to 205 cm; length 36 to 68 cm; width 68.8 to 145 cm |
| Distribution end date | 2026-05-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 104 | Weight 161 kg | In distribution |
| 104 | In distribution | |
| 104 | Height 205 cm | In distribution |
| 104 | Weight 43.2 kg | In distribution |
| 104 | Weight 90 kg | In distribution |
| 102 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| NeuroSITE | Neuronetics Inc. | 1 |
| OCD MT Cap | Neuronetics Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K183303 | 2019-03-08 |
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.