Altms Magnetic Stimulation Therapy System (Blossom TMS Therapy System)
The ALTMS Magnetic Stimulation Therapy System, also called Blossom TMS, delivers noninvasive magnetic pulses to stimulate cortical neurons. It is indicated for adults with major depressive…
The ALTMS Magnetic Stimulation Therapy System, also called Blossom TMS, delivers noninvasive magnetic pulses to stimulate cortical neurons. It is indicated for adults with major depressive disorder who have not achieved satisfactory improvement with antidepressant medication in the current episode.
A computerized system controls the pulses, which induce electrical currents in selected regions of the cerebral cortex. A standing arm holds the coil in position during treatment.
Listed Item
ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System)_SW Protocol Change ver
Treatment Control
Treatment is prescribed and supervised by a licensed physician, with motor threshold and coil position established before stimulation. The described protocol update allows inter-train intervals from 11 to 26 seconds rather than a fixed 26-second interval.
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 | Remed Co., Ltd., South Korea |
|---|---|
| FDA product code | OBP |
| Device type | Transcranial Magnetic Stimulator |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5805 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K220625 |
| Record published | 2022-05-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity up to 80 % RH; Storage environment temperature -10 to 40 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity up to 80 % RH; Handling environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B-01 | In distribution | |
| C-01 | 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 |
| Saint | Magnus Medical Inc. | 3 |
| SenStar Treatment Link | Neuronetics Inc. | 2 |
| Ampa One System | Neuromodulatory Devices & Applications | 2 |
Showing 12 of 98. All products under Transcranial Magnetic Stimulator
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220625 | 2022-04-06 |
| K202537 | 2021-11-26 |
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.