Cleared Traditional

ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000 (K863815) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K863815 · Elcot, Inc. · Neurology device
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Jun 1987
Decision
245d
Days
Class 2
Risk

K863815 is an FDA 510(k) clearance for the ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000. 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 June 2, 1987 after a review of 245 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

Submission Details

510(k) Number K863815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1986
Decision Date June 02, 1987
Days to Decision 245 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 148d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.