Cleared Traditional

K153224 - VitalStim Plus Electrotherapy System

K153224 is the FDA 510(k) clearance for VitalStim Plus Electrotherapy System by Djo, LLC. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K153224 · Djo, LLC · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Feb 2016
Decision
103d
Days
Class 2
Risk

K153224 is an FDA 510(k) clearance for the VitalStim(R) Plus Electrotherapy System. 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 February 17, 2016 after a review of 103 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 Djo, LLC devices

Submission Details

510(k) Number K153224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2015
Decision Date February 17, 2016
Days to Decision 103 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 115d · This submission: 103d
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 115
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