Cleared Traditional

K881114 - EMPI MODEL 989, TENS

K881114 is an FDA 510(k) clearance for EMPI MODEL 989, manufactured by Empi. The device is a Class 2 Neurology device with 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.

FDA 510(k) Submission Details - K881114

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
118d faster than avg
Panel avg: 149d · This submission: 31d
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 557
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K881114.
DS-200 AND DS-400 T.E.N.S.
K881832 · Delta Marketing, Inc. · Jul 1988
EASY TENS
K881704 · American Imex · May 1988
INTERCEPT T.E.N.S. DEVICE
K880492 · Medical Design & Manufacturing Corp. · Apr 1988
SCHULDT* PC* - DUAL CHANNEL TENS
K880980 · Schuldt Laboratories, Inc. · Apr 1988
PREMIER 10S (TENS)
K881424 · American Imex · Apr 1988
ULTIMA XS (TENS)
K880751 · American Imex · Apr 1988
K881114 · EMPI MODEL 989, TENS
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