Deep Transcranial Magnetic Stimulation (DTMS) System— 510(k) K210201

Substantially Equivalent

Brainsway , Ltd.

FDA 510(k) clearance K210201 for Deep Transcranial Magnetic Stimulation (DTMS) System, Substantially Equivalent on 2021-08-17. Applicant: Brainsway , Ltd..

Clearance details

Applicant: Brainsway , Ltd.
Product code: Code OBP
Advisory panel: Neurology
Date received: 2021-01-25
Decision date: 2021-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jerusalem, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.