Cleared Traditional

K881114 - EMPI MODEL 989

K881114 is the FDA 510(k) clearance for EMPI MODEL 989 by Empi. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K881114 · Empi · Neurology device
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Apr 1988
Decision
31d
Days
Class 2
Risk

K881114 is an FDA 510(k) clearance for the EMPI MODEL 989, 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 April 15, 1988 after a review of 31 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 Empi devices

Submission Details

510(k) Number K881114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1988
Decision Date April 15, 1988
Days to Decision 31 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
117d faster than avg
Panel avg: 148d · This submission: 31d
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 94
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K881114.
MEDIMOD(TM), MODEL 8900
K890705 · Medical Devices, Inc. · Mar 1989
EMPI MODEL 727,NMS
K882631 · Empi · Sep 1988
MEDIPAC II EC (TM), MODEL 7900
K882820 · Medical Devices, Inc. · Aug 1988
ULTRAPAC II SX PLUS (TM)
K872657 · Medical Devices, Inc. · Aug 1987
MEDTENS(TM), MODEL NUMBER 7725
K871722 · Medtronic Vascular · Jul 1987
OMEGA T100
K870666 · Henley Intl. · Apr 1987