Saint
A software for personalizing and optimizing magnetic brain stimulation treatment.
3manufacturers in China registered for this device type
3catalogue 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 | Magnus Medical Inc., United States |
|---|---|
| FDA product code | OBP |
| Device type | Transcranial Magnetic Stimulator |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5805 |
| Establishment | Manufacturer |
| 510(k) | K220177 |
| Record published | 2024-04-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SAINT-AK-2001 | In distribution | |
| SAINT-NMS-1001 | In distribution | |
| Magnus Cloud Software | 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 |
| NeuroStar Head Support System, Domestic | Neuronetics 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 |
|---|---|
| K220177 | 2022-09-01 |
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.