Cleared Traditional

K912289 - ULTIMA XS, MODIFICATION

K912289 is an FDA 510(k) clearance for ULTIMA XS, manufactured by American Imex. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K912289

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.

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 278
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K912289.
LOW BACK STRIP (OR) K-BACK
K912381 · Katecho, Inc. · Jan 1992
TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL
K914871 · Labeltape Meditect, Inc. · Dec 1991
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