Cleared Traditional

K894388 - ZIMMER TENS

K894388 is the FDA 510(k) clearance for ZIMMER TENS by American Imex. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K894388 · American Imex · Neurology device
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Aug 1989
Decision
24d
Days
Class 2
Risk

K894388 is an FDA 510(k) clearance for the ZIMMER 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 August 10, 1989 after a review of 24 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 K894388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1989
Decision Date August 10, 1989
Days to Decision 24 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 148d · This submission: 24d
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 K894388.
TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K895211 · Henley Intl. · Oct 1989
TTS2600
K895334 · Henley Intl. · Oct 1989
TENZCARE STIMULATOR 6890
K891992 · 3M Company · Oct 1989
EMPI, MODEL 489, TENS
K890604 · Empi · Jun 1989
MEDIMOD(TM), MODEL 8900
K890705 · Medical Devices, Inc. · Mar 1989
HEPAX (TENS)
K882154 · Avl Scientific Corp. · Sep 1988