Cleared Traditional

K083302 - LIFECARE ELECTRODES

K083302 is an FDA 510(k) clearance for LIFECARE ELECTRODES, manufactured by Everyway Medical Instruments Co.,Ltd. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K083302 · Everyway Medical Instruments Co.,Ltd · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
266d
Days
Class 2
Risk

K083302 is an FDA 510(k) clearance for the LIFECARE ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Everyway Medical Instruments Co.,Ltd (Roswell, US). The FDA issued a Cleared decision on August 3, 2009 after a review of 266 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.

FDA 510(k) Submission Details - K083302

510(k) Number K083302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2008
Decision Date August 03, 2009
Days to Decision 266 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 149d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

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 440
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K083302.
EMSI GARMENT ELECTRODES
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K083758 · The Electrode Store, Inc. · Aug 2009
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BIS CLICK SENSOR/CABLE
K091854 · Aspect Medical Systems, Inc. · Jul 2009
GUARDIAN 150 ELECTRODE
K083756 · Selectivemed Components, Inc. · Jun 2009
K083302 · LIFECARE ELECTRODES
Download PDF FDA Summary Everyway Medical Inst…