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FDA 510(k)

Ultimate rTMS

K-Number: K243460 · 2025-04-17

ApplicantBrain Ultimate, Inc.
Decision Date2025-04-17
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ultimate rTMS is a medical device manufactured by Brain Ultimate, Inc.. It received FDA 510(k) clearance on 2025-04-17 under approval number K243460. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultimate rTMS?

Ultimate rTMS 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 K243460.

When was Ultimate rTMS approved by the FDA?

Ultimate rTMS received FDA 510(k) clearance on 2025-04-17, under approval number K243460.

What company makes Ultimate rTMS?

Ultimate rTMS is manufactured by Brain Ultimate, Inc..

What is the FDA product code for Ultimate rTMS?

The FDA product code for Ultimate rTMS is OBP.

Other Devices by Brain Ultimate, Inc.

K230735Ultimate rTMS; Yingchi rTMS K243459Ultimate rTMS for OCD (M-series)

Related Devices (Code: OBP)

K160309Neurosoft TMSTeleemg, LLC K161519NeuroStar TMS Therapy SystemNeuronetics, Inc. K160703NeuroStar TMS Therapy SystemNeuronetics, Inc. K173441Neurosoft TMS (also CloudTMS)Teleemg, LLC K171902Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc K172667MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S

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.

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