Cleared Traditional

K041920 - INFINITY PLUS ELECTROTHERAPY SYSTEM

K041920 is the FDA 510(k) clearance for INFINITY PLUS ELECTROTHERAPY SYSTEM by Empi. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K041920 · Empi · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
189d
Days
Class 2
Risk

K041920 is an FDA 510(k) clearance for the INFINITY PLUS ELECTROTHERAPY SYSTEM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Empi (North Attleboro, US). The FDA issued a Cleared decision on January 21, 2005 after a review of 189 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Empi devices

Submission Details

510(k) Number K041920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2004
Decision Date January 21, 2005
Days to Decision 189 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 115d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 114
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K041920.
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K021100 · Empi · Jun 2002
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K013770 · Rich-Mar Corp. · Jan 2002