K203735 is an FDA 510(k) clearance for the Brainsway Deep TMS System. Classified as Transcranial Magnetic Stimulator (product code OBP), Class II - Special Controls.
Submitted by Brainsway , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on April 23, 2021 after a review of 123 days - within the typical 510(k) review window.
This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5805 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.
View all Brainsway , Ltd. devices
NCT04679753
Completed
Interventional
Industry-sponsored
Brainsway DTMS for Treatment of MDD Using iTBS
Brainsway Deep TMS System for Treatment of Major Depressive Disorder (MDD) Using Intermittent Theta Burst Stimulation (iTBS) Protocol
| Condition studied |
Major Depressive Disorder |
| Study design |
Parallel |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Oluremi Adefolarin, MD |
| Sponsor |
Brainsway
(industry)
|
Started 2019-01-01
→
Primary completion 2020-07-01
Primary outcome
The primary outcome measure was the change from baseline in HDRS-21 scores at the 5 week visit.
Secondary outcome
HDRS-21 Response and Remission rates
Study completed - no results published.
This trial concluded in 2020 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov