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)
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.

View all Myotronics-Noromed, Inc. devices

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
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · 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 23
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K013399.
Freespira
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EAR MUFFINS
K012384 · Bio-Logic Systems Corp. · Oct 2001
EMG RETRAINER
K972487 · Chattanooga Group, Inc. · Sep 1997
J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS
K945826 · Medical Device Inspection Co., Inc. · Aug 1995