QuickVision Ultimate rTMS— 510(k) K261228
Substantially EquivalentBrain Ultimate, Inc.
FDA 510(k) clearance K261228 for QuickVision Ultimate rTMS, Substantially Equivalent on 2026-08-14. Applicant: Brain Ultimate, Inc.. Device class: 2.
Summary
Brain Ultimate's QuickVision Ultimate rTMS is filed under product code OBP, transcranial magnetic stimulators. The record gives no model numbers or further description.
Class II, 21 CFR 882.5805. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Brain Ultimate filed from Alpharetta, Georgia. The decision came 121 calendar days after FDA received it (April 15 to August 14, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Brain Ultimate, Inc.
- Product code
- Product code OBP
- Device class
- Class 2
- Regulation
- 21 CFR 882.5805
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
Recent devices under product code OBP
view all- K260396 — KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)
- K260691 — BTL-699
- K260189 — MagVenture Accelerated TMS (aTMS) Therapy System
- K260560 — Apollo TMS Therapy System; Apollo light TMS Therapy System
- K252358 — Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
More clearances from Brain Ultimate, Inc.
view allAdverse events under product code OBP
product code OBP- Injury
- 270
- Total
- 270
Source: openFDA MAUDE database, through . 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.