Cleared Traditional

K163547 - MaxxiGold Electrode 48

K163547 is the FDA 510(k) clearance for MaxxiGold Electrode 48 by Neurovirtual USA, Inc.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K163547 · Neurovirtual USA, Inc. · Neurology device
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Apr 2017
Decision
116d
Days
Class 2
Risk

K163547 is an FDA 510(k) clearance for the MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Neurovirtual USA, Inc. (Doral, US). The FDA issued a Cleared decision on April 11, 2017 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Neurovirtual USA, Inc. devices

Submission Details

510(k) Number K163547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2016
Decision Date April 11, 2017
Days to Decision 116 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 148d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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.

Regulatory Peers - GXY Electrode, Cutaneous

All 142
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