Cleared Abbreviated

K103719 - LIFECARE CONDUCTIVE GARMENTS

K103719 is an FDA 510(k) clearance for LIFECARE CONDUCTIVE GARMENTS, manufactured by Everyway Medical Instruments Co.,Ltd. The device is a Class 2 Neurology device with product code GXY cleared through the Abbreviated 510(k) pathway after a 246-day FDA review.

K103719 · Everyway Medical Instruments Co.,Ltd · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
246d
Days
Class 2
Risk

K103719 is an FDA 510(k) clearance for the LIFECARE CONDUCTIVE GARMENTS. 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 24, 2011 after a review of 246 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Everyway Medical Instruments Co.,Ltd devices

FDA 510(k) Submission Details - K103719

510(k) Number K103719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2010
Decision Date August 24, 2011
Days to Decision 246 days
Submission Type Abbreviated
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
98d slower than avg
Panel avg: 148d · This submission: 246d
Pathway characteristics
Standards-based clearance path.

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 K103719.
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