Not Cleared Direct

DEN240014 - ARC-EX System (FDA 510(k) Clearance)

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

DEN240014 · Onward Medical, Inc. · Neurology device
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Dec 2024
Decision
266d
Days
Class 2
Risk

DEN240014 is an FDA 510(k) submission (not cleared) for the ARC-EX System. Classified as Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation (product code SDO), Class II - Special Controls.

Submitted by Onward Medical, Inc. (Boston, US). The FDA issued a Not Cleared (DENG) decision on December 19, 2024 after a review of 266 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.5851 - the FDA neurology 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. Elevated predicate reliance profile. With 266 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 Onward Medical, Inc. devices

Submission Details

510(k) Number DEN240014 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 28, 2024
Decision Date December 19, 2024
Days to Decision 266 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 148d · This submission: 266d
Pathway characteristics

Device Classification

Product Code SDO Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5851
Definition A Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation Is A Device That Can Be Programmed To Apply An Electrical Current Via Electrodes On A Patient's Skin Over The Spine To Improve Muscle Strength And Sensation After Neurological Deficit.
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 Neurology devices follow this clearance model.