Cleared Traditional

K880924 - INTER TRON 4000

K880924 is the FDA 510(k) clearance for INTER TRON 4000 by Diversified Chiropractic Systems. It is a Class 2 Neurology device (product code LIH) cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K880924 · Diversified Chiropractic Systems · Neurology device
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Oct 1988
Decision
223d
Days
Class 2
Risk

K880924 is an FDA 510(k) clearance for the INTER TRON 4000. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Diversified Chiropractic Systems (Olathe, US). The FDA issued a Cleared decision on October 13, 1988 after a review of 223 days - an extended review cycle.

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.

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Submission Details

510(k) Number K880924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1988
Decision Date October 13, 1988
Days to Decision 223 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 148d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.