Cleared Traditional

K163547 - MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96

K163547 is an FDA 510(k) clearance for MaxxiGold Electrode 48, manufactured by Neurovirtual USA, Inc.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K163547

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
Combination Product No
PCCP Authorized No
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.

GXY Device Classification - Class 2, Special Controls

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 290
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K163547.
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