Deep Transcranial Magnetic Stimulation (Dtms) System
Deep TMS system 104 with H1 - Refurbished
3manufacturers in China registered for this device type
10catalogue numbers in this listing
8510(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 | Brainsway Ltd., Israel |
|---|---|
| FDA product code | OBP |
| Device type | Transcranial Magnetic Stimulator |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5805 |
| Establishment | Manufacturer |
| 510(k) | K173540 |
| Record published | 2026-03-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 80 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
| Sizes | Weight 43.2 to 161 kg; height 110 to 205 cm; length 36 to 68 cm; width 68.8 to 145 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 104 | Weight 43.2 kg | In distribution |
| 102/102B | In distribution | |
| 104 | In distribution | |
| 104 | In distribution | |
| 104 | In distribution | |
| 104 | Weight 161 kg | In distribution |
| 104 | In distribution | |
| 104 | In distribution | |
| 104 | Weight 90 kg | In distribution |
| 104 | Weight 161 kg | 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 |
| 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 |
|---|---|
| K251391 | 2025-11-07 |
| K251449 | 2025-09-13 |
| K222196 | 2024-05-31 |
| K220819 | 2022-08-26 |
| K210201 | 2021-08-17 |
| K203735 | 2021-04-23 |
| K173540 | 2018-05-03 |
| K122288 | 2013-01-07 |
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.