Cleared Traditional

MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841 (K993600) - FDA 510(k) Clearance

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

K993600 · Nisha Communication Industries · Neurology device
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Feb 2001
Decision
469d
Days
Class 2
Risk

K993600 is an FDA 510(k) clearance for the MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Nisha Communication Industries (Jodhpur-342003, IN). The FDA issued a Cleared decision on February 5, 2001 after a review of 469 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Nisha Communication Industries devices

Submission Details

510(k) Number K993600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1999
Decision Date February 05, 2001
Days to Decision 469 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
321d slower than avg
Panel avg: 148d · This submission: 469d
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.