Cleared Special

K173441 - Neurosoft TMS (also CloudTMS)

K173441 is an FDA 510(k) clearance for Neurosoft TMS (also CloudTMS), manufactured by Teleemg, LLC. The device is a Class 2 Neurology device with product code OBP cleared through the Special 510(k) pathway after a 37-day FDA review.

K173441 · Teleemg, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
37d
Days
Class 2
Risk

K173441 is an FDA 510(k) clearance for the Neurosoft TMS (also CloudTMS). Classified as Transcranial Magnetic Stimulator (product code OBP), Class II - Special Controls.

Submitted by Teleemg, LLC (Woburn, US). The FDA issued a Cleared decision on December 13, 2017 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5805 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Teleemg, LLC devices

FDA 510(k) Submission Details - K173441

510(k) Number K173441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 149d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

OBP Device Classification - Class 2, Special Controls

Product Code OBP Transcranial Magnetic Stimulator
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Makromed, Inc.
Barry Ashar

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OBP Transcranial Magnetic Stimulator

All 68
Devices cleared under the same product code (OBP) and FDA review panel - the closest regulatory comparables to K173441.
HORIZON TMS Therapy System
K180907 · Magstim Company, Ltd. · Aug 2018
Apollo TMS Therapy System
K180313 · Mag & More GmbH · May 2018
Brainsway Deep (DTMS) System
K173540 · Brainsway , Ltd. · May 2018
Nexstim Navigated Brain Therapy (NBT) System 2
K171902 · Nexstim Plc · Nov 2017
MagVita TMS Therapy w/MagPro R20
K172667 · Tonica Elektronik A/S · Oct 2017
HORIZON Therapy System
K171051 · Magstim Company, Ltd. · Sep 2017