Cleared Abbreviated

NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM (K111279) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K111279 · Zynex Medical, Inc. · Physical Medicine device
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Sep 2011
Decision
138d
Days
Class 2
Risk

K111279 is an FDA 510(k) clearance for the NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Zynex Medical, Inc. (Lone Tree, US). The FDA issued a Cleared decision on September 20, 2011 after a review of 138 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Zynex Medical, Inc. devices

Submission Details

510(k) Number K111279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2011
Decision Date September 20, 2011
Days to Decision 138 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 115d · This submission: 138d
Pathway characteristics
Standards-based clearance path.

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 74
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K111279.
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K003596 · Smith & Nephew, Inc. · Jun 2001
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
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MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
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