Cleared Traditional

K893604 - TENS PREP

K893604 is the FDA 510(k) clearance for TENS PREP by Smith & Nephew United, Inc.. It is a Class 2 Neurology device (product code GYB) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K893604 · Smith & Nephew United, Inc. · Neurology device
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Nov 1989
Decision
189d
Days
Class 2
Risk

K893604 is an FDA 510(k) clearance for the TENS PREP. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on November 21, 1989 after a review of 189 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - 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 Smith & Nephew United, Inc. devices

Submission Details

510(k) Number K893604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1989
Decision Date November 21, 1989
Days to Decision 189 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
41d slower than avg
Panel avg: 148d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GYB Media, Electroconductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1275
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 - GYB Media, Electroconductive

All 24
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K893604.
LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL
K933804 · Cadwell Laboratories, Inc. · Mar 1994
ELECTROCONDUCTIVE MEDIA
K904377 · Henley Intl. · Nov 1991
CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275)
K901630 · Henley Intl. · Jul 1990
SKIN PURE
K862799 · Nihon Kohden America, Inc. · Nov 1986
ELEFIX ELECTRODE CREAM
K860210 · Nihon Kohden America, Inc. · Jul 1986
ECG & ULTRASOUND GELS, CREAMS & LOTION
K803151 · Abco Dealers, Inc. · Dec 1980