FDA Registration
Active
🇮🇱 Israel
BRAINSWAY LTD.
Reg #: 3010300912
·
FEI: 3010300912
·
Expires 2026
Products
3
Proprietary Names
9
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- BRAINSWAY LTD.
- Registration Number
- 3010300912
- FEI Number
- 3010300912
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 16 Hartom Str., Har Hahotzvim
- City
- Jerusalem
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K203735
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 |
| Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | QCI | Class 2 | Neurology | No | 2020-08-13 |
| Transcranial Magnetic Stimulation System For Smoking Cessation | QMD | Class 2 | Neurology | No | 2021-11-14 |
Proprietary Names
BrainsWay Deep TMS System for Treatment of Major Depressive Disorder (MDD) using iTBS (Model 102 & 104)
BrainsWay Deep TMS System for Treatment of Obsessive Compulsive Disorder (OCD) (Model 104)
BrainsWay Deep TMS System for Smoking Cessation (Model 104)
BrainsWay Deep TMS System for Treatment of Major Depressive Disorder (MDD) (Model 102)
BrainsWay Deep TMS System for Treatment of Major Depressive Disorder (MDD) (Model 104)
BrainsWay Deep TMS System for Treatment of Obsessive Compulsive Disorder (OCD) (Model 102)
BrainsWay Deep TMS system
BrainsWay Deep TMS System for Treatment of Decreasing Anxiety Symptoms in MDD (Model 102 & 104)
BrainsWay Deep TMS System for Smoking Cessation (Model 102)
Establishment Types
Manufacture Medical Device