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FDA 510(k)

CloudTMS Edge

K-Number: K250689 · 2025-09-14

ApplicantTeleemg, LLC
Decision Date2025-09-14
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CloudTMS Edge is a medical device manufactured by Teleemg, LLC. It received FDA 510(k) clearance on 2025-09-14 under approval number K250689. 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 CloudTMS Edge?

CloudTMS Edge is a medical device that received FDA 510(k) clearance on 2025-09-14. It is manufactured by Teleemg, LLC. The 510(k) number is K250689.

When was CloudTMS Edge approved by the FDA?

CloudTMS Edge received FDA 510(k) clearance on 2025-09-14, under approval number K250689.

What company makes CloudTMS Edge?

CloudTMS Edge is manufactured by Teleemg, LLC.

What is the FDA product code for CloudTMS Edge?

The FDA product code for CloudTMS Edge is OBP.

Other Devices by Teleemg, LLC

K160309Neurosoft TMS K173441Neurosoft TMS (also CloudTMS) K233742CloudTMS Edge for OCD K221129CloudTMS for OCD

Related Devices (Code: OBP)

K160309Neurosoft TMSTeleemg, LLC K161519NeuroStar TMS Therapy SystemNeuronetics, Inc. K160703NeuroStar TMS Therapy SystemNeuronetics, Inc. K173441Neurosoft TMS (also CloudTMS)Teleemg, LLC K171902Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc K172667MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S

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.

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