Cleared Traditional

K201290 - Medline DeNovo 4Pro Electrical Stimulat...

K201290 is the FDA 510(k) clearance for Medline DeNovo 4Pro Electrical Stimulat... by Medline Industries, Inc.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K201290 · Medline Industries, Inc. · Physical Medicine device
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Sep 2020
Decision
130d
Days
Class 2
Risk

K201290 is an FDA 510(k) clearance for the Medline DeNovo 4Pro Electrical Stimulation Device. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Northfield, US). The FDA issued a Cleared decision on September 21, 2020 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 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K201290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2020
Decision Date September 21, 2020
Days to Decision 130 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
15d slower than avg
Panel avg: 115d · This submission: 130d
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 134
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