Cleared Traditional

K912289 - ULTIMA XS

K912289 is the FDA 510(k) clearance for ULTIMA XS by American Imex. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K912289 · American Imex · Neurology device
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Nov 1991
Decision
183d
Days
Class 2
Risk

K912289 is an FDA 510(k) clearance for the ULTIMA XS, MODIFICATION. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by American Imex (Irvine, US). The FDA issued a Cleared decision on November 22, 1991 after a review of 183 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 American Imex devices

Submission Details

510(k) Number K912289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1991
Decision Date November 22, 1991
Days to Decision 183 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 148d · This submission: 183d
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 126
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K912289.
TEAM-MC II
K921828 · Henley Intl. · Sep 1992
ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A
K915210 · Biomedical Life Systems, Inc. · May 1992
MEDTRONIC MODEL 90002065 MF TENS SYSTEM
K911963 · Medtronic Vascular · Dec 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