Cleared Traditional

K031930 - HIGH SPEED EMG MODULE

K031930 is an FDA 510(k) clearance for HIGH SPEED EMG MODULE, manufactured by Medical Measurement Systems B.V.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K031930 · Medical Measurement Systems B.V. · Neurology device
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Mar 2004
Decision
254d
Days
Class 2
Risk

K031930 is an FDA 510(k) clearance for the HIGH SPEED EMG MODULE. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Medical Measurement Systems B.V. (Enschede Overijssel, NL). The FDA issued a Cleared decision on March 3, 2004 after a review of 254 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Measurement Systems B.V. devices

FDA 510(k) Submission Details - K031930

510(k) Number K031930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2003
Decision Date March 03, 2004
Days to Decision 254 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 148d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 55
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K031930.
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