Cleared Traditional

K901630 - CHEMPAD(TM)

K901630 is the FDA 510(k) clearance for CHEMPAD(TM) by Henley Intl.. It is a Class 2 Neurology device (product code GYB) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K901630 · Henley Intl. · Neurology device
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Jul 1990
Decision
98d
Days
Class 2
Risk

K901630 is an FDA 510(k) clearance for the CHEMPAD(TM), ELECTROCONDUCTIVE MEDIA (882.1275). Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on July 16, 1990 after a review of 98 days - within the typical 510(k) review window.

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 Henley Intl. devices

Submission Details

510(k) Number K901630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1990
Decision Date July 16, 1990
Days to Decision 98 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
50d faster than avg
Panel avg: 148d · This submission: 98d
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 K901630.
OMNI PREP GEL
K933797 · Cadwell Laboratories, Inc. · May 1994
LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL
K933804 · Cadwell Laboratories, Inc. · Mar 1994
ELECTROCONDUCTIVE MEDIA
K904377 · Henley Intl. · Nov 1991
TENS PREP
K893604 · Smith & Nephew United, Inc. · Nov 1989
SKIN PURE
K862799 · Nihon Kohden America, Inc. · Nov 1986
ELEFIX ELECTRODE CREAM
K860210 · Nihon Kohden America, Inc. · Jul 1986