Cleared Special

K090023 - IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E

K090023 is an FDA 510(k) clearance for IF SERIES TRUE SINE INTERFERENTIAL STIM..., manufactured by Well-Life Healthcare Limited. The device is a Class 2 Neurology device with product code LIH cleared through the Special 510(k) pathway after a 25-day FDA review.

K090023 · Well-Life Healthcare Limited · Neurology device
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Jan 2009
Decision
25d
Days
Class 2
Risk

K090023 is an FDA 510(k) clearance for the IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Well-Life Healthcare Limited (Yunghe City, Taipei County, TW). The FDA issued a Cleared decision on January 30, 2009 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Well-Life Healthcare Limited devices

FDA 510(k) Submission Details - K090023

510(k) Number K090023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2009
Decision Date January 30, 2009
Days to Decision 25 days
Submission Type Special
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
123d faster than avg
Panel avg: 148d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 34
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K090023.
EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
K110509 · Everyway Medical Instruments Co.,Ltd · Jun 2011
MAX-IF1000
K100246 · Bio Protech, Inc. · Nov 2010
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
K092763 · Well-Life Healthcare Limited · Oct 2009
INFINITY ELECTROTHERAPY SYSTEM
K042057 · Empi · Dec 2004
INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
K040007 · Biomedical Life Systems, Inc. · Jul 2004
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
K040824 · Biomedical Life Systems, Inc. · Apr 2004