Cleared Traditional

K894388 - ZIMMER TENS

K894388 is an FDA 510(k) clearance for ZIMMER TENS, 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 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.

FDA 510(k) Submission Details - K894388

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 149d · This submission: 24d
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 605
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K894388.
ACUDATA INDICATENS MODEL 5M
K890087 · Acudata Software · Sep 1989
STERLING TENS
K891118 · Armstrong Industries, Inc. · Sep 1989
LUMISCOPE MODEL 1000/APCC MODEL 1000
K894127 · Lumiscope Co., Inc. · Sep 1989
TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR
K884972 · Futuremed Div. of Future Impex Corp. · Jul 1989
NSD 8CS8 - TENS DEVICE
K892408 · Future Medical Products, Inc. · Jun 1989
MODIFIED MRL NEUROPROBE SYSTEM V
K884869 · Medical Research Laboratories, Inc. · Jun 1989
K894388 · ZIMMER TENS
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