Cleared Traditional

K043407 - INF 4160, MODEL D-FJ27F

K043407 is an FDA 510(k) clearance for INF 4160, 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 63-day FDA review.

K043407 · Fuji Dynamics Limited · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
63d
Days
Class 2
Risk

K043407 is an FDA 510(k) clearance for the INF 4160, MODEL D-FJ27F. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Fuji Dynamics Limited (Dong Guan, Guangdong, CN). The FDA issued a Cleared decision on February 11, 2005 after a review of 63 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.

FDA 510(k) Submission Details - K043407

510(k) Number K043407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2004
Decision Date February 11, 2005
Days to Decision 63 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
86d faster than avg
Panel avg: 149d · This submission: 63d
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 67
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K043407.
EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507
K070890 · Everlife Medical Equipment Co., Ltd. · Jun 2007
IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2
K060975 · Theratech, Inc. · May 2006
DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE
K052289 · Biowave Corporation · Dec 2005
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
K043407 · INF 4160, MODEL D-FJ27F
Download PDF FDA Summary Fuji Dynamics Limited