Cleared Traditional

INTER TRON 4000 (K880924) - FDA 510(k) Clearance

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

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.

View all Diversified Chiropractic Systems devices

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.