Cleared Traditional

K123099 - Best-AV2 Pro-Sport(tm)

K123099 is an FDA 510(k) clearance for Best-AV2 Pro-Sport(tm), manufactured by Avazzia, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 598-day FDA review.

K123099 · Avazzia, Inc. · Neurology device
Download Printable Device Report (PDF)
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May 2014
Decision
598d
Days
Class 2
Risk

K123099 is an FDA 510(k) clearance for the Best-AV2 Pro-Sport(tm). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Avazzia, Inc. (Dallas, US). The FDA issued a Cleared decision on May 23, 2014 after a review of 598 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Avazzia, Inc. devices

FDA 510(k) Submission Details - K123099

510(k) Number K123099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2012
Decision Date May 23, 2014
Days to Decision 598 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
449d slower than avg
Panel avg: 149d · This submission: 598d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 339
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