Cleared Traditional

K093324 - EMPI CONTINUUM

K093324 is the FDA 510(k) clearance for EMPI CONTINUUM by Empi. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K093324 · Empi · Physical Medicine device
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Mar 2010
Decision
133d
Days
Class 2
Risk

K093324 is an FDA 510(k) clearance for the EMPI CONTINUUM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Empi (Hixson, US). The FDA issued a Cleared decision on March 5, 2010 after a review of 133 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 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 K093324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2009
Decision Date March 05, 2010
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
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
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