Cleared Traditional

K092780 - INF 4160 PLUS, MODEL D-FJ31F

K092780 is an FDA 510(k) clearance for INF 4160 PLUS, manufactured by Fuji Dynamics Limited. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K092780 · Fuji Dynamics Limited · Neurology device
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Jan 2010
Decision
119d
Days
Class 2
Risk

K092780 is an FDA 510(k) clearance for the INF 4160 PLUS, MODEL D-FJ31F. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Fuji Dynamics Limited (Kowloon, Hong Kong, CN). The FDA issued a Cleared decision on January 7, 2010 after a review of 119 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 Fuji Dynamics Limited devices

FDA 510(k) Submission Details - K092780

510(k) Number K092780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2009
Decision Date January 07, 2010
Days to Decision 119 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
29d faster than avg
Panel avg: 148d · This submission: 119d
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 35
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