Cleared Abbreviated

K124016 - EMPI PHOENIX

K124016 is an FDA 510(k) clearance for EMPI PHOENIX, manufactured by Djo, LLC. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Abbreviated 510(k) pathway after a 130-day FDA review.

K124016 · Djo, LLC · Physical Medicine device
Download Printable Device Report (PDF)
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May 2013
Decision
130d
Days
Class 2
Risk

K124016 is an FDA 510(k) clearance for the EMPI PHOENIX. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Djo, LLC (Vista, US). The FDA issued a Cleared decision on May 6, 2013 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Djo, LLC devices

FDA 510(k) Submission Details - K124016

510(k) Number K124016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2012
Decision Date May 06, 2013
Days to Decision 130 days
Submission Type Abbreviated
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
15d slower than avg
Panel avg: 115d · This submission: 130d
Pathway characteristics
Standards-based clearance path.

IPF Device Classification - Class 2, Special Controls

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 235
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K124016.
MULTISTIM
K132137 · Metron Medical Australia, Pty, Ltd. · Sep 2013
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MUSCLE STIMULATION SYSTEM
K123642 · Niveus Medical, Inc. · Mar 2013
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K120922 · Selectivemed Components, Inc. · Feb 2013
FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
K113010 · Famidoc Technology Co., Ltd. · Dec 2012