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 a medical device manufactured by Teleemg, LLC. It received FDA 510(k) clearance on 2023-12-22 under approval 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. It is manufactured by Teleemg, LLC. The 510(k) number is K233742.
When was CloudTMS Edge for OCD approved by the FDA?
CloudTMS Edge for OCD received FDA 510(k) clearance on 2023-12-22, under approval number K233742.
What company makes CloudTMS Edge for OCD?
CloudTMS Edge for OCD is manufactured by Teleemg, LLC.
What is the FDA product code for CloudTMS Edge for OCD?
The FDA product code for CloudTMS Edge for OCD is QCI.
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K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStarNeuronetics, Inc.
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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.