Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CloudTMS Edge for OCD

K-Number: K233742 · 2023-12-22

ApplicantTeleemg, LLC
Decision Date2023-12-22
Product CodeQCI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CloudTMS Edge for OCD is the device name listed in this FDA 510(k) record. The listed applicant is Teleemg, LLC. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K233742. 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 CloudTMS Edge for OCD?

CloudTMS Edge for OCD is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Teleemg, LLC. The 510(k) number is K233742.

When did CloudTMS Edge for OCD receive FDA 510(k) clearance?

CloudTMS Edge for OCD received FDA 510(k) clearance on 2023-12-22, under 510(k) number K233742.

Who is the listed applicant for CloudTMS Edge for OCD?

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

What is the FDA product code for CloudTMS Edge for OCD?

The FDA product code for CloudTMS Edge for OCD is QCI.

Other records listing Teleemg, LLC 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.

K250689CloudTMS EdgeK221129CloudTMS for OCDK173441Neurosoft TMS (also CloudTMS)K160309Neurosoft TMS

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.

K260402MeRT SystemWave NeuroscienceK243459Ultimate rTMS for OCD (M-series)Brain Ultimate, Inc.K230657BTL-99-OCBTL Industries, Inc.K231350OCD 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

View on FDA Database →

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

↑