Cleared Traditional

K930535 - IF400

K930535 is an FDA 510(k) clearance for IF400, manufactured by Skylark Device Co., Ltd.. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 497-day FDA review.

K930535 · Skylark Device Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
497d
Days
Class 2
Risk

K930535 is an FDA 510(k) clearance for the IF400. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Skylark Device Co., Ltd. (Taipei, Taiwan, R.O.C., TW). The FDA issued a Cleared decision on June 14, 1994 after a review of 497 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 Skylark Device Co., Ltd. devices

FDA 510(k) Submission Details - K930535

510(k) Number K930535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1993
Decision Date June 14, 1994
Days to Decision 497 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
349d slower than avg
Panel avg: 148d · This submission: 497d
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 33
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K930535.
RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE
K952089 · Rich-Mar Corp. · Aug 1995
ISOTRON III
K941815 · Excel Tech. , Ltd. · May 1995
THERATOUCH 4.7
K932868 · Rich-Mar Corp. · Jul 1994
INTERFERENTIAL STIMULATOR MODEL IMF4150/A
K925687 · Biomedical Life Systems, Inc. · Mar 1993
INTELECT IFC2
K924666 · Chattanooga Group, Inc. · Mar 1993
DYNATRON 400
K924319 · Dynatronics Corp. · Jan 1993