Cleared Traditional

K890605 - EMPI ISLAND TENS ELECTRODE

K890605 is the FDA 510(k) clearance for EMPI ISLAND TENS ELECTRODE by Empi. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K890605 · Empi · Neurology device
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Mar 1989
Decision
38d
Days
Class 2
Risk

K890605 is an FDA 510(k) clearance for the EMPI ISLAND TENS ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Empi (Arden Hills, US). The FDA issued a Cleared decision on March 16, 1989 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 K890605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1989
Decision Date March 16, 1989
Days to Decision 38 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
110d faster than avg
Panel avg: 148d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 139
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K890605.
MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN
K896485 · Empi · Dec 1989
TENZCARE ELECTRODE 6862
K893793 · 3M Company · Nov 1989
PROMONTORY STIMULATING ELECTRODE
K895081 · Cadwell Laboratories, Inc. · Nov 1989
EMPI MULTIDAY TENS DISPOSABLE ELECTRODE
K890614 · Empi · Mar 1989
EMPI REUSEABLE PIN-STYLE TENS ELECTRODE
K890747 · Empi · Mar 1989
MODIFIED JELTRODE(TM) ELECTRODES DEEMED
K884348 · Henley Intl. · Dec 1988