FDA Registration
Active
🇮🇱 Israel
BrainsWay Deep TMS System for Treatment of Decreasing Anxiety Symptoms in MDD (Model 102 & 104)
Reg #: 3010300912
·
FEI: 3010300912
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BRAINSWAY LTD.
- Registration Number
- 3010300912
- FEI Number
- 3010300912
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 16 Hartom Str., Har Hahotzvim
- City
- Jerusalem
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K210201
Owner / Operator
- Firm Name
- Brainsway Ltd.
- Operator Number
- 10044527
- Address
- 16 Hartom Str., Har Hahotzvim
- City
- Jerusalem
- State
- IL-JM
- Postal Code
- 9777516
- Country
- IL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transcranial Magnetic Stimulator | OBP | Class 2 | Neurology | No | 2021-11-14 |
Proprietary Names
BrainsWay Deep TMS System for Treatment of Decreasing Anxiety Symptoms in MDD (Model 102 & 104)
Establishment Types
Manufacture Medical Device