Cleared Traditional

K862602 - AXION IV GOLDLINE SERIES

K862602 is an FDA 510(k) clearance for AXION IV GOLDLINE SERIES, manufactured by Ventura Medical Electronics. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K862602 · Ventura Medical Electronics · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1986
Decision
167d
Days
Class 2
Risk

K862602 is an FDA 510(k) clearance for the AXION IV GOLDLINE SERIES. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Ventura Medical Electronics (Shawnee, US). The FDA issued a Cleared decision on December 22, 1986 after a review of 167 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 Ventura Medical Electronics devices

FDA 510(k) Submission Details - K862602

510(k) Number K862602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1986
Decision Date December 22, 1986
Days to Decision 167 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 148d · This submission: 167d
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 291
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K862602.
BACPAC (TM), MODEL 6500
K864968 · Medical Devices, Inc. · Mar 1987
ECLIPSE+, MODEL NUMBER 7723
K865048 · Medtronic Vascular · Feb 1987
CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.
K863469 · Cordis Corp. · Feb 1987
ULTRAPAC II SD (TM)
K862337 · Medical Devices, Inc. · Aug 1986
EMPI MODEL GLS 450, TENS
K861830 · Empi · Jul 1986
EMPI MODEL 720 NMS, TENS
K861451 · Empi · Jul 1986