Cleared Traditional

K062641 - BODY-STIM

K062641 is an FDA 510(k) clearance for BODY-STIM, 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 236-day FDA review.

K062641 · Avazzia, Inc. · Neurology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K062641

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.

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 151
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K062641.
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
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SELECT TENS, MODEL 4600S
K061650 · Empi · Jan 2007
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1
K061476 · Biomedical Life Systems, Inc. · Jul 2006
MODEL BMLS03-7
K042711 · Biomedical Life Systems, Inc. · Mar 2005