CloudTMS Edge for OCD
The CloudTMS Edge stimulator is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD)
3manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Neurosoft, OOO |
|---|---|
| FDA product code | QCI |
| Device type | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5802 |
| 510(k) | K233742 |
| Record published | 2024-01-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Irbis cooling unit | In distribution | |
| Main unit | 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 |
| 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 |
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.