Cleared Traditional

K110509 - EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908

K110509 is an FDA 510(k) clearance for EVERYWAY INTERFERNTIAL STIMULATOR, manufactured by Everyway Medical Instruments Co.,Ltd. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K110509 · Everyway Medical Instruments Co.,Ltd · Neurology device
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Jun 2011
Decision
118d
Days
Class 2
Risk

K110509 is an FDA 510(k) clearance for the EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Everyway Medical Instruments Co.,Ltd (Roswell, US). The FDA issued a Cleared decision on June 20, 2011 after a review of 118 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Everyway Medical Instruments Co.,Ltd devices

FDA 510(k) Submission Details - K110509

510(k) Number K110509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2011
Decision Date June 20, 2011
Days to Decision 118 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
30d faster than avg
Panel avg: 148d · This submission: 118d
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 42
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K110509.
Avid IF2
K183692 · Vision Quest Industries Inc./Dba VQ Orthocare · Jun 2019
GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
K122944 · Gemore Technology Co, Ltd. · Dec 2012
VECTTOR VT-200
K121662 · Alan Neuromedical Technologies, LLC · Nov 2012
MAX-IF1000
K100246 · Bio Protech, Inc. · Nov 2010
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
K092763 · Well-Life Healthcare Limited · Oct 2009
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E
K090023 · Well-Life Healthcare Limited · Jan 2009