Cleared Special

EMG SYSTEM (K111687) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K111687 · Myotronics-Noromed, Inc. · Neurology device
Download Printable Device Report (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.

View all Myotronics-Noromed, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 148d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.