Cleared Traditional

K050788 - EVERLIFE

K050788 is an FDA 510(k) clearance for EVERLIFE, manufactured by Everlife Medical Instrument Co., Ltd.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K050788 · Everlife Medical Instrument Co., Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
46d
Days
Class 2
Risk

K050788 is an FDA 510(k) clearance for the EVERLIFE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Everlife Medical Instrument Co., Ltd. (Hsin Chu City, TW). The FDA issued a Cleared decision on May 13, 2005 after a review of 46 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K050788

510(k) Number K050788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2005
Decision Date May 13, 2005
Days to Decision 46 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
103d faster than avg
Panel avg: 149d · This submission: 46d
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 409
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K050788.
CUTANEOUS ELECTRODE
K052188 · Rhythmlink International, LLC · Aug 2005
AMBU NEUROLINE GROUND
K051529 · Ambu, Inc. · Aug 2005
EZ-STIK ELECTRODES
K050469 · Naimco, Inc. · May 2005
BRAINET KIT
K043009 · Jordan Neuroscience, Inc. · Jan 2005
MANTRA ELECTRODE
K041902 · Mantra Intl. (Hk) , Ltd. · Sep 2004
PROTENS ELECTRODE
K042301 · Bio Protech, Inc. · Sep 2004
K050788 · EVERLIFE
Download PDF FDA Summary Everlife Medical Inst…