Cleared Traditional

K953356 - EMG RECORDING RING ELECTRODE

K953356 is an FDA 510(k) clearance for EMG RECORDING RING ELECTRODE, manufactured by Chalgren Enterprises, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K953356 · Chalgren Enterprises, Inc. · Neurology device
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Jan 1996
Decision
189d
Days
Class 2
Risk

K953356 is an FDA 510(k) clearance for the EMG RECORDING RING ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Chalgren Enterprises, Inc. (Gilroy, US). The FDA issued a Cleared decision on January 22, 1996 after a review of 189 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 Chalgren Enterprises, Inc. devices

FDA 510(k) Submission Details - K953356

510(k) Number K953356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date January 22, 1996
Days to Decision 189 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
41d slower than avg
Panel avg: 148d · This submission: 189d
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 207
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K953356.
MODEL 1240, SMALL E NET
K960885 · Physiometrix, Inc. · Apr 1996
HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500
K960732 · Physiometrix, Inc. · Apr 1996
EMG DISC RECORDING ELECTRODE
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EMG DISC RECORDING ELECTRODE
K953361 · Chalgren Enterprises, Inc. · Jan 1996
DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123
K944314 · Bio-Logic Systems Corp. · Jan 1996
EMG DISC RECORDING ELECTRODE WITH PIN
K952690 · Chalgren Enterprises, Inc. · Dec 1995