Cleared Traditional

K042057 - INFINITY ELECTROTHERAPY SYSTEM

K042057 is an FDA 510(k) clearance for INFINITY ELECTROTHERAPY SYSTEM, manufactured by Empi. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K042057 · Empi · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
140d
Days
Class 2
Risk

K042057 is an FDA 510(k) clearance for the INFINITY ELECTROTHERAPY SYSTEM. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Empi (North Attleboro, US). The FDA issued a Cleared decision on December 17, 2004 after a review of 140 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 Empi devices

FDA 510(k) Submission Details - K042057

510(k) Number K042057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2004
Decision Date December 17, 2004
Days to Decision 140 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
8d faster than avg
Panel avg: 148d · This submission: 140d
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 40
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K042057.
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
INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
K040007 · Biomedical Life Systems, Inc. · Jul 2004
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
K040824 · Biomedical Life Systems, Inc. · Apr 2004
DYNATRON STS
K010565 · Dynatronics Corp. · May 2001