Cleared Traditional

K854721 - NEMECTRODYN MODEL 2 & ENDOVAC 2

K854721 is an FDA 510(k) clearance for NEMECTRODYN MODEL 2 & ENDOVAC 2, manufactured by Nemectron Medical, Inc.. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K854721 · Nemectron Medical, Inc. · Neurology device
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Mar 1986
Decision
104d
Days
Class 2
Risk

K854721 is an FDA 510(k) clearance for the NEMECTRODYN MODEL 2 & ENDOVAC 2. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Nemectron Medical, Inc. (Temecula, US). The FDA issued a Cleared decision on March 6, 1986 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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 Nemectron Medical, Inc. devices

FDA 510(k) Submission Details - K854721

510(k) Number K854721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1985
Decision Date March 06, 1986
Days to Decision 104 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 148d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIH Device Classification - Class 2, Special Controls

Product Code LIH Interferential Current Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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.