Cleared Traditional

K000947 - ULTRASTIM ELECTRODE, MODEL US4040

K000947 is an FDA 510(k) clearance for ULTRASTIM ELECTRODE, manufactured by Axelgaard Mfg. Co., Ltd.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K000947 · Axelgaard Mfg. Co., Ltd. · Neurology device
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Jun 2000
Decision
85d
Days
Class 2
Risk

K000947 is an FDA 510(k) clearance for the ULTRASTIM ELECTRODE, MODEL US4040. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Axelgaard Mfg. Co., Ltd. (Fallbrook, US). The FDA issued a Cleared decision on June 16, 2000 after a review of 85 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 Axelgaard Mfg. Co., Ltd. devices

FDA 510(k) Submission Details - K000947

510(k) Number K000947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2000
Decision Date June 16, 2000
Days to Decision 85 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
63d faster than avg
Panel avg: 148d · This submission: 85d
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 301
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K000947.
KM-10 TENS ELECTRODE
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ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110
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ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106
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MODEL 4300 PSARRAY EEG ELECTRODE SET
K001055 · Physiometrix, Inc. · May 2000
ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
K994330 · Aspect Medical Systems, Inc. · Jan 2000
ULTRA-GARMENT ELECTRODE
K993130 · Newwave Medical, LLC · Dec 1999