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FDA 510(k)

MeRT System

K-Number: K260402 · 2026-06-03

ApplicantWave Neuroscience
Decision Date2026-06-03
Product CodeQCI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MeRT System is the device name listed in this FDA 510(k) record. The listed applicant is Wave Neuroscience. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K260402. 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 MeRT System?

MeRT System is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Wave Neuroscience. The 510(k) number is K260402.

When did MeRT System receive FDA 510(k) clearance?

MeRT System received FDA 510(k) clearance on 2026-06-03, under 510(k) number K260402.

Who is the listed applicant for MeRT System?

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

What is the FDA product code for MeRT System?

The FDA product code for MeRT System is QCI.

Related Devices (Code: QCI)

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.

K243459Ultimate rTMS for OCD (M-series)Brain Ultimate, Inc.K230657BTL-99-OCBTL Industries, Inc.K233742CloudTMS Edge for OCDTeleemg, LLCK231350OCD MT Cap (85-00397-000)NeuroneticsK221129CloudTMS for OCDTeleemg, LLCK212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStarNeuronetics, 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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