Cleared Traditional

K100246 - MAX-IF1000

K100246 is an FDA 510(k) clearance for MAX-IF1000, manufactured by Bio Protech, Inc.. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K100246 · Bio Protech, Inc. · Neurology device
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Nov 2010
Decision
301d
Days
Class 2
Risk

K100246 is an FDA 510(k) clearance for the MAX-IF1000. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Bio Protech, Inc. (Dallas, US). The FDA issued a Cleared decision on November 24, 2010 after a review of 301 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Bio Protech, Inc. devices

FDA 510(k) Submission Details - K100246

510(k) Number K100246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2010
Decision Date November 24, 2010
Days to Decision 301 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 148d · This submission: 301d
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 41
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K100246.
GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
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VECTTOR VT-200
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K110509 · Everyway Medical Instruments Co.,Ltd · Jun 2011
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
INF 4160, MODEL D-FJ27F
K043407 · Fuji Dynamics Limited · Feb 2005