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FDA 510(k)

Ultimate rTMS; Yingchi rTMS

K-Number: K230735 · 2023-09-13

ApplicantBrain Ultimate, Inc.
Decision Date2023-09-13
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ultimate rTMS; Yingchi rTMS is the device name listed in this FDA 510(k) record. The listed applicant is Brain Ultimate, Inc.. It received FDA 510(k) clearance on 2023-09-13 under 510(k) number K230735. 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; Yingchi rTMS?

Ultimate rTMS; Yingchi rTMS is a medical device that received FDA 510(k) clearance on 2023-09-13. The listed applicant is Brain Ultimate, Inc.. The 510(k) number is K230735.

When did Ultimate rTMS; Yingchi rTMS receive FDA 510(k) clearance?

Ultimate rTMS; Yingchi rTMS received FDA 510(k) clearance on 2023-09-13, under 510(k) number K230735.

Who is the listed applicant for Ultimate rTMS; Yingchi rTMS?

The FDA 510(k) record lists Brain Ultimate, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultimate rTMS; Yingchi rTMS?

The FDA product code for Ultimate rTMS; Yingchi rTMS is OBP.

Other records listing Brain Ultimate, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261228QuickVision Ultimate rTMSK243460Ultimate rTMSK243459Ultimate rTMS for OCD (M-series)

Related Devices (Code: OBP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbHK260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/SK253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK251653SPRY TMS Therapy System (0550)Soterix Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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