Brain Ultimate, Inc.

FDA Regulatory Profile

Brain Ultimate, Inc. appears in FDA public data with 0 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 14, 2026.

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K261228QuickVision Ultimate rTMSAugust 14, 2026
K243459Ultimate rTMS for OCD (M-series)April 17, 2025
K243460Ultimate rTMSApril 17, 2025
K230735Ultimate rTMS; Yingchi rTMSSeptember 13, 2023