Cleared Special

K013399 - MODEL MES-9000/EMG SYSTEM

K013399 is an FDA 510(k) clearance for MODEL MES-9000/EMG SYSTEM, manufactured by Myotronics-Noromed, Inc.. The device is a Class 2 Neurology device with product code HCC cleared through the Special 510(k) pathway after a 29-day FDA review.

K013399 · Myotronics-Noromed, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
29d
Days
Class 2
Risk

K013399 is an FDA 510(k) clearance for the MODEL MES-9000/EMG SYSTEM. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Myotronics-Noromed, Inc. (Tukwila, US). The FDA issued a Cleared decision on November 13, 2001 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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.

FDA 510(k) Submission Details - K013399

510(k) Number K013399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2001
Decision Date November 13, 2001
Days to Decision 29 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
120d faster than avg
Panel avg: 149d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 Peers - HCC Device, Biofeedback

All 102
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K013399.
POLYGRAM NET BIOFEEDBACK APPLICATION
K041244 · Medtronic Vascular · Aug 2004
RESPERATE
K020399 · Intercure , Ltd. · Jul 2002
SONDREX P.A.L. SYSTEM
K010388 · Ohmeda Medical · Dec 2001
EAR MUFFINS
K012384 · Bio-Logic Systems Corp. · Oct 2001
MODIFICATION TO A620 EEG
K012011 · Stoelting Co. · Oct 2001
INSIGHT MILLENNIUM PLUS
K011964 · Fasstech · Sep 2001
K013399 · MODEL MES-9000/EMG SYSTEM
Download PDF FDA Summary Myotronics-Noromed, I…