Cleared Special

K111687 - EMG SYSTEM

K111687 is an FDA 510(k) clearance for 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 105-day FDA review.

K111687 · Myotronics-Noromed, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
105d
Days
Class 2
Risk

K111687 is an FDA 510(k) clearance for the EMG SYSTEM. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Myotronics-Noromed, Inc. (Kent, US). The FDA issued a Cleared decision on September 29, 2011 after a review of 105 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K111687

510(k) Number K111687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2011
Decision Date September 29, 2011
Days to Decision 105 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
44d faster than avg
Panel avg: 149d · This submission: 105d
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
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K111687 · EMG SYSTEM
Download PDF FDA Summary Myotronics-Noromed, I…