Not Cleared Direct

DEN230051 - Myocene (FDA 510(k) Clearance)

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

DEN230051 · Myocene · Physical Medicine device
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Jan 2025
Decision
540d
Days
Class 2
Risk

DEN230051 is an FDA 510(k) submission (not cleared) for the Myocene. Classified as Neuromuscular Stimulator And Exercise Evaluation System (product code SDX), Class II - Special Controls.

Submitted by Myocene (Liège, BE). The FDA issued a Not Cleared (DENG) decision on January 17, 2025 after a review of 540 days.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 882.1871 - the FDA physical medicine device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 540 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Myocene devices

Submission Details

510(k) Number DEN230051 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 27, 2023
Decision Date January 17, 2025
Days to Decision 540 days
Submission Type Direct
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
425d slower than avg
Panel avg: 115d · This submission: 540d
Pathway characteristics

Device Classification

Product Code SDX Neuromuscular Stimulator And Exercise Evaluation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1871
Definition A Neuromuscular Stimulator And Evaluation System Is A Device That Applies Neuromuscular Stimulation And Measures A Neuromuscular Response, For The Purpose Of Evaluating Exercise Capacity And Performance Or Informing Athletic Training Decisions.
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.