Cleared Traditional

HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES (K022917) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K022917 · Home Care Technology Co., Ltd. · Neurology device
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Mar 2003
Decision
182d
Days
Class 2
Risk

K022917 is an FDA 510(k) clearance for the HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Home Care Technology Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on March 4, 2003 after a review of 182 days - an extended review 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: 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 Home Care Technology Co., Ltd. devices

Submission Details

510(k) Number K022917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2002
Decision Date March 04, 2003
Days to Decision 182 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 148d · This submission: 182d
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

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