Cleared Traditional

Neurosoft TMS

K160309 · Teleemg, LLC · Neurology

Dec 2016

Decision

322d

Days

Class 2

Risk

About This 510(k) Submission

K160309 is an FDA 510(k) clearance for the Neurosoft TMS, 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 22, 2016, 322 days after receiving the submission on February 4, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number	K160309 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2016
Decision Date	December 22, 2016
Days to Decision	322 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.