Cleared Traditional

K993600 - MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841

K993600 is an FDA 510(k) clearance for MULTI INTERFERENTIAL STIMULATOR, manufactured by Nisha Communication Industries. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 469-day FDA review.

K993600 · Nisha Communication Industries · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K993600

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
320d slower than avg
Panel avg: 149d · This submission: 469d
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 67
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K993600.
SMARTWAVE IF 2000
K003631 · Newwave Medical, LLC · Aug 2001
DYNATRON STS
K010565 · Dynatronics Corp. · May 2001
DYNATRON STS RX
K010948 · Dynatronics Corp. · May 2001
SD-730 IF-SDS, PERFECT PULSE IF-SDS
K992652 · Skylark Device & Systems Co., Ltd. · Feb 2000
TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR
K990129 · Therapy Link, Inc. · Apr 1999
IF-727 INTERFERENTIAL STIMULATOR
K974585 · Skylark Device Co., Ltd. · Mar 1998
K993600 · MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841
Download PDF FDA Summary Nisha Communication I…