Cleared Traditional

K890604 - EMPI, MODEL 489, TENS

K890604 is an FDA 510(k) clearance for EMPI, manufactured by Empi. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K890604 · Empi · Neurology device
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Jun 1989
Decision
115d
Days
Class 2
Risk

K890604 is an FDA 510(k) clearance for the EMPI, MODEL 489, TENS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Empi (Arden Hills, US). The FDA issued a Cleared decision on June 1, 1989 after a review of 115 days - within the typical 510(k) review window.

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 Empi devices

FDA 510(k) Submission Details - K890604

510(k) Number K890604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1989
Decision Date June 01, 1989
Days to Decision 115 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
33d faster than avg
Panel avg: 148d · This submission: 115d
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 228
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K890604.
TENZCARE STIMULATOR 6890
K891992 · 3M Company · Oct 1989
TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR
K884972 · Futuremed Div. of Future Impex Corp. · Jul 1989
MODIFIED MRL NEUROPROBE SYSTEM V
K884869 · Medical Research Laboratories, Inc. · Jun 1989
MEDIMOD(TM), MODEL 8900
K890705 · Medical Devices, Inc. · Mar 1989
HEPAX (TENS)
K882154 · Avl Scientific Corp. · Sep 1988
EMPI MODEL 727,NMS
K882631 · Empi · Sep 1988