FDA applicant
Brain Ultimate, Inc.
FDA records 4 decisions for Brain Ultimate, Inc. (Alpharetta, GA) from 2023 to 2026: 4 510(k) clearances. Most are in product codes OBP (Transcranial Magnetic Stimulator) and QCI (Transcranial Magnetic Stimulation System For…). Since 2016 its 510(k)s took a median of 160 days from receipt to decision, against 125 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Brain Ultimate, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Brain Ultimate, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Brain”
FDA records each applicant name separately; these may or may not be the same firm.