Cleared Traditional

CloudTMS Edge

K250689 · Teleemg, LLC · Neurology
Sep 2025
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K250689 is an FDA 510(k) clearance for the CloudTMS Edge, a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP), submitted by Teleemg, LLC (Los Angeles, US). The FDA issued a Cleared decision on September 14, 2025, 192 days after receiving the submission on March 6, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number K250689 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2025
Decision Date September 14, 2025
Days to Decision 192 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OBP — Transcranial Magnetic Stimulator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5805
Definition A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder.