Cleared Traditional

K974585 - IF-727 INTERFERENTIAL STIMULATOR

K974585 is an FDA 510(k) clearance for IF-727 INTERFERENTIAL STIMULATOR, 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 88-day FDA review.

K974585 · Skylark Device Co., Ltd. · Neurology device
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Mar 1998
Decision
88d
Days
Class 2
Risk

K974585 is an FDA 510(k) clearance for the IF-727 INTERFERENTIAL STIMULATOR. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Skylark Device Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on March 6, 1998 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Skylark Device Co., Ltd. devices

FDA 510(k) Submission Details - K974585

510(k) Number K974585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1997
Decision Date March 06, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 148d · This submission: 88d
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 32
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K974585.
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
K040824 · Biomedical Life Systems, Inc. · Apr 2004
DYNATRON STS
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DYNATRON STS RX
K010948 · Dynatronics Corp. · May 2001
DYNATRON 525
K961261 · Dynatronics Corp. · Sep 1996
ISOTRON III, ISOTRON IV
K955387 · Excel Tech. , Ltd. · Mar 1996
MULTI III, IV
K955860 · Excel Tech. , Ltd. · Mar 1996