Cleared Special

K231350 - OCD MT Cap (85-00397-000)
(FDA 510(k) Clearance)

K231350 · Neuronetics · Neurology

Jun 2023

Decision

30d

Days

Class 2

Risk

K231350 is an FDA 510(k) clearance for the OCD MT Cap (85-00397-000). This device is classified as a Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder (Class II — Special Controls, product code QCI).

Submitted by Neuronetics (Malvern, US). The FDA issued a Cleared decision on June 8, 2023, 30 days after receiving the submission on May 9, 2023.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5802. 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)..

Submission Details

510(k) Number	K231350 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 2023
Decision Date	June 08, 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).