Ultimate rTMS— 510(k) K243460

Name: FDA 510(k) clearance K243460
Creator: U.S. Food and Drug Administration
Published: 2025-04-17

Substantially Equivalent

Brain Ultimate, Inc.

FDA 510(k) clearance K243460 for Ultimate rTMS, Substantially Equivalent on 2025-04-17. Applicant: Brain Ultimate, Inc.. Device class: 2.

Clearance details

Applicant: Brain Ultimate, Inc.
Product code: Code OBP
Device class: Class 2
Regulation: 21 CFR 882.5805
Advisory panel: Neurology
Date received: 2024-11-08
Decision date: 2025-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OBP

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K260396 — KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)2026-09-06
K260691 — BTL-6992026-08-23
K261228 — QuickVision Ultimate rTMS2026-08-14
K260189 — MagVenture Accelerated TMS (aTMS) Therapy System2026-05-22
K260560 — Apollo TMS Therapy System; Apollo light TMS Therapy System2026-05-22

More clearances from Brain Ultimate, Inc.

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K243459 — Ultimate rTMS for OCD (M-series)2025-04-17
K230735 — Ultimate rTMS; Yingchi rTMS2023-09-13

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.