# Brain Ultimate, Inc.

- Location (FDA's records): Alpharetta, GA
- FDA decisions: 4 (2023–2026): 4 510(k) clearances
- Product codes: OBP (3), QCI (1)
- 510(k) review time since 2016: median 160 days, against 125 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tonica Elektronik A/S: 4 (https://510kreport.com/company/tonica-elektronik-a-s)
- The Magstim Company, Ltd.: 1 (https://510kreport.com/company/magstim)
- Eemagine Medical Imaging Solutions GmbH: 1 (https://510kreport.com/company/eemagine-medical-imaging-solutions)

## Firms that cite its devices most
- Fidelity BioPharma Co.: 1 (https://510kreport.com/company/fidelity-biopharma)

## Its most-cited devices
- K243460: Ultimate rTMS (2025), cited by 1
- K230735: Ultimate rTMS; Yingchi rTMS (2023), cited by 1

## Recent decisions
- K261228: QuickVision Ultimate rTMS (Aug 14, 2026)
- K243460: Ultimate rTMS (Apr 17, 2025)
- K243459: Ultimate rTMS for OCD (M-series) (Apr 17, 2025)
- K230735: Ultimate rTMS; Yingchi rTMS (Sep 13, 2023)

Source page: https://510kreport.com/company/brain-ultimate