Cleared Traditional

K062641 - BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1 (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K062641 · Avazzia, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Apr 2007
Decision
236d
Days
Class 2
Risk

K062641 is an FDA 510(k) clearance for the BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1. 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 April 30, 2007 after a review of 236 days - an extended review cycle.

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: 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 Avazzia, Inc. devices

Submission Details

510(k) Number K062641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2006
Decision Date April 30, 2007
Days to Decision 236 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
88d slower than avg
Panel avg: 148d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 604
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K062641.
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