Brainsway Ltd.
Jerusalem, IL
BRAINSWAY LTD. appears in FDA device records in Jerusalem, IL. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Brainsway Ltd. between 2013 and 2025. The busiest year on record is 2021, with 3. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251391 | BrainsWay Deep TMS System | OBP | Substantially Equivalent | |
| K251449 | BrainsWay Deep TMS System | OBP | Substantially Equivalent | |
| K222196 | Deep TMS System | OBP | Substantially Equivalent | |
| K220819 | BrainsWay Deep TMS System | OBP | Substantially Equivalent | |
| K210201 | Deep Transcranial Magnetic Stimulation (DTMS) System | OBP | Substantially Equivalent | |
| K203735 | Brainsway Deep TMS System | OBP | Substantially Equivalent | |
| K203616 | Brainsway Deep (DTMS) System | QMD | Substantially Equivalent | |
| K200957 | Brainsway Deep TMS System | QMD | Substantially Equivalent | |
| K183303 | Brainsway Deep TMS System | QCI | Substantially Equivalent | |
| K173540 | Brainsway Deep (DTMS) System | OBP | Substantially Equivalent | |
| K122288 | BRAINSWAY DEEP TMS SYSTEM | OBP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010300912 | 3010300912 | BRAINSWAY LTD. | 16 Hartom Str., Jerusalem 9777516 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain