Ultimate rTMS— 510(k) K243460
Substantially EquivalentBrain Ultimate, Inc.
FDA 510(k) clearance K243460 for Ultimate rTMS, Substantially Equivalent on 2025-04-17. Applicant: Brain Ultimate, Inc..
Clearance details
- Applicant
- Brain Ultimate, Inc.
- Product code
- Code OBP
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
Adverse 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.