Cleared Traditional

K153224 - VitalStim(R) Plus Electrotherapy System

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

K153224 · Djo, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K153224

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 116d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 503
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K153224.
StimSox(TM) System
K151922 · Stimmed, LLC · Apr 2016
Chattanooga Revolution Wireless
K153696 · Djo, LLC · Apr 2016
geko(TM) Plus R-2 Neuromuscular Stimulator
K160299 · Firstkind Limited · Apr 2016
geko T-2 Neuromuscular Stimulator
K152677 · Firstkind Limited · Oct 2015
Muscle Stimulation System 110
K150742 · Niveus Medical, Inc. · Jul 2015
QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator
K150413 · Cymedica Orthopedics, Inc. · Apr 2015
K153224 · VitalStim(R) Plus Electrotherapy System
Download PDF FDA Summary Djo, LLC