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Sign in to claim this brandBrainsway , Ltd.
US
Last updated May 30, 2026
What Brainsway , Ltd. makes
The company manufactures magnetic neural stimulation systems, including deep transcranial magnetic stimulation (DTMS) devices designed for targeted brain stimulation. Key components include the H1-Coil, cooling systems, power supply modules, and positioning modules, all integrated into systems like the Brainsway Deep TMS System. These devices are used for therapeutic applications involving neural modulation.
The portfolio consists of Class II medical devices, regulated under FDA pathways including 510(k) clearance and the Unique Device Identifier (UDI) program. These systems are listed in the United States, where the manufacturer is based.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Brainsway, Ltd. manufacture?
Brainsway, Ltd. specializes in magnetic neural stimulation systems, with a focus on deep transcranial magnetic stimulation (DTMS) devices. These systems are designed to deliver targeted brain stimulation for therapeutic purposes. The company’s portfolio includes components like the H1-Coil, cooling systems, power supply modules, and positioning modules, all integrated into systems such as the Brainsway Deep TMS System.
Where is Brainsway, Ltd. based, and where are its devices listed?
Brainsway, Ltd. is headquartered in the United States. Its devices are listed in the FDA’s regulatory databases, including the 510(k) clearance pathway and the Unique Device Identifier (UDI) program, which are key regulatory frameworks for Class II medical devices in the U.S.
How are Brainsway’s devices classified under FDA regulations?
Brainsway’s devices fall under Class II classification in the FDA’s regulatory system. This classification applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as those used for deep brain stimulation therapies.
What regulatory pathways does Brainsway use to authorize its devices in the U.S.?
Brainsway’s devices are authorized through the FDA’s 510(k) clearance process and the Unique Device Identifier (UDI) program. The 510(k) pathway demonstrates that a device is substantially equivalent to a legally marketed predicate device, while the UDI system ensures traceability and identification of medical devices in the market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- brainsway.com
- —
- —
- [email protected]
- Phone
- +972547734900
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 531873441
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| H1-Coil | 102B | FDA UDI | Class II | Active |
| Cart Module | 102B | FDA UDI | Class II | Active |
| Cooling System - 24V | 102B | FDA UDI | Class II | Active |
| Power Supply Module - 115V | 102B | FDA UDI | Class II | Active |
| Positioning Module 102B | 102B | FDA UDI | Class II | Active |
| Brainsway Deep Tms System | K122288 | FDA 510(k) | Class II | Active |
| Brainsway Deep (DTMS) System | K173540 | FDA 510(k) | Class II | Active |
| BrainsWay Deep TMS System | K251449 | FDA 510(k) | Class II | Active |
| Deep Transcranial Magnetic Stimulation (DTMS) System | K210201 | FDA 510(k) | Class II | Active |
| Brainsway Deep TMS System | K183303 | FDA 510(k) | Class II | Active |
| BrainsWay Deep TMS System | K220819 | FDA 510(k) | Class II | Active |
| Brainsway Deep (DTMS) System | K203616 | FDA 510(k) | Class II | Active |
| Brainsway Deep TMS System | K203735 | FDA 510(k) | Class II | Active |
| BrainsWay Deep TMS System | K251391 | FDA 510(k) | Class II | Active |
| Deep TMS System | K222196 | FDA 510(k) | Class II | Active |
| Brainsway Deep TMS System | K200957 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Brainsway Ltd. Jerusalem · IL FEI 3010300912