Cleared Special

CloudTMS Edge for OCD

K233742 · Teleemg, LLC · Neurology

Dec 2023

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K233742 is an FDA 510(k) clearance for the CloudTMS Edge for OCD, a Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder (Class II — Special Controls, product code QCI), submitted by Teleemg, LLC (Los Angeles, US). The FDA issued a Cleared decision on December 22, 2023, 30 days after receiving the submission on November 22, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5802.

Submission Details

510(k) Number	K233742 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 22, 2023
Decision Date	December 22, 2023
Days to Decision	30 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	QCI — Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5802
Definition	External Device That Uses Magnetic Fields To Induce Neural Activity In The Cerebral Cortex To Treat Neurological And Psychiatric Disorders And Conditions. It Is Not Intended For Applying Or Focusing Magnetic Fields Towards Brain Areas Outside Cerebral Cortex (e.g., Cerebellum).