Cleared Traditional

K931768 - INTERFERENTIAL CURRENT THERAPY UNIT

K931768 is an FDA 510(k) clearance for INTERFERENTIAL CURRENT THERAPY UNIT, manufactured by Lumiscope Co., Inc.. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K931768 · Lumiscope Co., Inc. · Neurology device
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Feb 1994
Decision
321d
Days
Class 2
Risk

K931768 is an FDA 510(k) clearance for the INTERFERENTIAL CURRENT THERAPY UNIT. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Lumiscope Co., Inc. (Edison, US). The FDA issued a Cleared decision on February 23, 1994 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Lumiscope Co., Inc. devices

FDA 510(k) Submission Details - K931768

510(k) Number K931768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1993
Decision Date February 23, 1994
Days to Decision 321 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 148d · This submission: 321d
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.

Regulatory Peers - LIH Interferential Current Therapy

All 41
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