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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 the device name listed in this FDA 510(k) record. The listed applicant is Teleemg, LLC. It received FDA 510(k) clearance on 2025-09-14 under 510(k) 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. The listed applicant is Teleemg, LLC. The 510(k) number is K250689.

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

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

Who is the listed applicant for CloudTMS Edge?

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?

The FDA product code for CloudTMS Edge is OBP.

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.

K233742CloudTMS Edge for OCDK221129CloudTMS for OCDK173441Neurosoft TMS (also CloudTMS)K160309Neurosoft TMS

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.

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 OyjK251653SPRY TMS Therapy System (0550)Soterix Medical, 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.

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