Cleared Traditional

K913373 - GLOBALCARE ELECTRODE

K913373 is an FDA 510(k) clearance for GLOBALCARE ELECTRODE, manufactured by Globalcare Intl., Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K913373 · Globalcare Intl., Inc. · Neurology device
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Aug 1991
Decision
31d
Days
Class 2
Risk

K913373 is an FDA 510(k) clearance for the GLOBALCARE ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Globalcare Intl., Inc. (Holyoke, US). The FDA issued a Cleared decision on August 29, 1991 after a review of 31 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.

View all Globalcare Intl., Inc. devices

FDA 510(k) Submission Details - K913373

510(k) Number K913373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1991
Decision Date August 29, 1991
Days to Decision 31 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
117d faster than avg
Panel avg: 148d · This submission: 31d
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 310
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K913373.
ELECTRODE
K912643 · Skylark Device Co., Ltd. · Feb 1992
K-STIM
K913031 · Katecho, Inc. · Jan 1992
ELECTRODE USING PROMEON RG-60 SERIES GEL
K915333 · Labeltape Meditect, Inc. · Jan 1992
VERSA-STIM ELECTRODE LINE MODIFIED
K911069 · Conmedcorp · Jul 1991
3M 6830 ELECTRODE
K905539 · 3M Healthcare · May 1991
NORTECH MODEL 86901000 ELECTRODE
K903427 · Andover Medical, Inc. · Aug 1990