Cleared Traditional

K012463 - LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL

K012463 is an FDA 510(k) clearance for LIFECARE 5*5 CM SQUARE, 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 188-day FDA review.

K012463 · Everyway Medical Instruments Co.,Ltd · Neurology device
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Feb 2002
Decision
188d
Days
Class 2
Risk

K012463 is an FDA 510(k) clearance for the LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE.... Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Everyway Medical Instruments Co.,Ltd (Shen Keng Hsiang,Taipei Hsien, TW). The FDA issued a Cleared decision on February 5, 2002 after a review of 188 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 Everyway Medical Instruments Co.,Ltd devices

FDA 510(k) Submission Details - K012463

510(k) Number K012463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2001
Decision Date February 05, 2002
Days to Decision 188 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
40d slower than avg
Panel avg: 148d · This submission: 188d
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 292
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K012463.
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