Cleared Traditional

K911144 - MF-500, MODIFICATION

K911144 is an FDA 510(k) clearance for MF-500, manufactured by Elcot, Inc.. The device is a Class 2 Neurology device with product code QGH cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K911144 · Elcot, Inc. · Neurology device
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Oct 1991
Decision
235d
Days
Class 2
Risk

K911144 is an FDA 510(k) clearance for the MF-500, MODIFICATION. Classified as Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder (product code QGH), Class II - Special Controls.

Submitted by Elcot, Inc. (New York, US). The FDA issued a Cleared decision on October 18, 1991 after a review of 235 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5940 - 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 Elcot, Inc. devices

FDA 510(k) Submission Details - K911144

510(k) Number K911144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1991
Decision Date October 18, 1991
Days to Decision 235 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 148d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QGH Device Classification - Class 2, Special Controls

Product Code QGH Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5940
Definition Catatonia Or A Severe Major Depressive Episode (mde) Associated With Major Depressive Disorder (mdd) Or Bipolar Disorder (bpd) In Patients Age 13 Years And Older Who Are Treatment-resistant Or Who Require A Rapid Response Due To The Severity Of Their Psychiatric Or Medical Condition.
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.