Cleared Traditional

K895295 - ULTIMA XS MICROCURRENT TENS

K895295 is the FDA 510(k) clearance for ULTIMA XS MICROCURRENT TENS by American Imex. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K895295 · American Imex · Neurology device
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Nov 1989
Decision
73d
Days
Class 2
Risk

K895295 is an FDA 510(k) clearance for the ULTIMA XS MICROCURRENT TENS. 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 6, 1989 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Imex devices

Submission Details

510(k) Number K895295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1989
Decision Date November 06, 1989
Days to Decision 73 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 148d · This submission: 73d
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 125
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K895295.
SYNAPS (TM)
K903828 · Henley Intl. · Jan 1991
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K896620 · Henley Intl. · Apr 1990
DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S
K895473 · Medical Devices, Inc. · Dec 1989
TTS2800
K895161 · Henley Intl. · Oct 1989
TTS2500
K895166 · Henley Intl. · Oct 1989
TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K895211 · Henley Intl. · Oct 1989