Ultimate rTMS for OCD (M-series)
K-Number: K243459 · 2025-04-17
ApplicantBrain Ultimate, Inc.
Decision Date2025-04-17
Product CodeQCI
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Ultimate rTMS for OCD (M-series) is a medical device manufactured by Brain Ultimate, Inc.. It received FDA 510(k) clearance on 2025-04-17 under approval number K243459. The device is classified under product code QCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ultimate rTMS for OCD (M-series)?
Ultimate rTMS for OCD (M-series) is a medical device that received FDA 510(k) clearance on 2025-04-17. It is manufactured by Brain Ultimate, Inc.. The 510(k) number is K243459.
When was Ultimate rTMS for OCD (M-series) approved by the FDA?
Ultimate rTMS for OCD (M-series) received FDA 510(k) clearance on 2025-04-17, under approval number K243459.
What company makes Ultimate rTMS for OCD (M-series)?
Ultimate rTMS for OCD (M-series) is manufactured by Brain Ultimate, Inc..
What is the FDA product code for Ultimate rTMS for OCD (M-series)?
The FDA product code for Ultimate rTMS for OCD (M-series) is QCI.
Other Devices by Brain Ultimate, Inc.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.