Cleared Traditional

K911814 - AXION 5, MODIFICATION

K911814 is an FDA 510(k) clearance for AXION 5, 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 181-day FDA review.

K911814 · Ventura Medical Electronics · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
181d
Days
Class 2
Risk

K911814 is an FDA 510(k) clearance for the AXION 5, MODIFICATION. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Ventura Medical Electronics (Merriam, US). The FDA issued a Cleared decision on October 15, 1991 after a review of 181 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 - K911814

510(k) Number K911814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1991
Decision Date October 15, 1991
Days to Decision 181 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 148d · This submission: 181d
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 290
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K911814.
MEDTRONIC MODEL 90002065 MF TENS SYSTEM
K911963 · Medtronic Vascular · Dec 1991
BIO TENS 601, 606 AND 608 (3000)
K912178 · Skylark Device Co., Ltd. · Oct 1991
TEAM-MC
K905672 · Henley Intl. · Oct 1991
DYNEX IIIB, MODEL 89002026
K913594 · Medtronic Vascular · Aug 1991
SX90 (TM),MODEL 4800S
K912348 · Medical Devices, Inc. · Jun 1991
ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A
K905230 · Biomedical Life Systems, Inc. · Jun 1991