Cleared Special

Neurosoft TMS (also CloudTMS)

K173441 · Teleemg, LLC · Neurology

Dec 2017

Decision

37d

Days

Class 2

Risk

About This 510(k) Submission

K173441 is an FDA 510(k) clearance for the Neurosoft TMS (also CloudTMS), a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP), submitted by Teleemg, LLC (Woburn, US). The FDA issued a Cleared decision on December 13, 2017, 37 days after receiving the submission on November 6, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number	K173441 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 06, 2017
Decision Date	December 13, 2017
Days to Decision	37 days
Submission Type	Special
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.