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FDA 510(k)

KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)

K-Number: K260396 · 2026-09-06

ApplicantFidelity BioPharma Co.
Decision Date2026-09-06
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) is the device name listed in this FDA 510(k) record. The listed applicant is Fidelity BioPharma Co.. It received FDA 510(k) clearance on 2026-09-06 under 510(k) number K260396. 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 KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)?

KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) is a medical device that received FDA 510(k) clearance on 2026-09-06. The listed applicant is Fidelity BioPharma Co.. The 510(k) number is K260396.

When did KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) receive FDA 510(k) clearance?

KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) received FDA 510(k) clearance on 2026-09-06, under 510(k) number K260396.

Who is the listed applicant for KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)?

The FDA 510(k) record lists Fidelity BioPharma Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)?

The FDA product code for KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) is OBP.

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.

K260691BTL-699BTL Industries, Inc.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 Oyj

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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