Cleared Traditional

Medline DeNovo 4Pro Electrical Stimulation Device

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

About This 510(k) Submission

K201290 is an FDA 510(k) clearance for the Medline DeNovo 4Pro Electrical Stimulation Device, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Medline Industries, Inc. (Northfield, US). The FDA issued a Cleared decision on September 21, 2020, 130 days after receiving the submission on May 14, 2020. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K201290 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code IPF — Stimulator, Muscle, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5850

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