Cleared Traditional

K022494 - HOME CARE JELLY

K022494 is an FDA 510(k) clearance for HOME CARE JELLY, manufactured by Roc Chinese-European Industrial Research Society. The device is a Class 2 Neurology device with product code GYB cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K022494 · Roc Chinese-European Industrial Research Society · Neurology device
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Dec 2002
Decision
126d
Days
Class 2
Risk

K022494 is an FDA 510(k) clearance for the HOME CARE JELLY. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Roc Chinese-European Industrial Research Society (Columbus, US). The FDA issued a Cleared decision on December 2, 2002 after a review of 126 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 Roc Chinese-European Industrial Research Society devices

FDA 510(k) Submission Details - K022494

510(k) Number K022494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2002
Decision Date December 02, 2002
Days to Decision 126 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 149d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYB Device Classification - Class 2, Special Controls

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 46
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K022494.
ELECTRO-GEL
K111717 · Electro-Cap Intl., Inc. · Jan 2012
THERA-CREAM, MODEL TCT004
K032239 · Prizm Medical, Inc. · Jul 2004
LEKTROGEL, MODEL LK3001
K030887 · Inmed Ltda. · Jun 2003
CONDUCTIVE GEL
K022006 · The Dezac Group · Sep 2002
MAVIDON MEDICAL ELECTRODE JELLY
K003924 · Mavidon Medical Products · Aug 2001
CONDUCTIVE GEL FOR ULTRASOUND
K002832 · Skylark Device & Systems Co., Ltd. · Aug 2001