Cleared Traditional

K954951 - TAYLOR GENERAL PURPOSE MONITORING ELECTRODE

K954951 is an FDA 510(k) clearance for TAYLOR GENERAL PURPOSE MONITORING ELECTRODE, manufactured by Taylor Industries, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K954951 · Taylor Industries, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
213d
Days
Class 2
Risk

K954951 is an FDA 510(k) clearance for the TAYLOR GENERAL PURPOSE MONITORING ELECTRODE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Taylor Industries, Inc. (New Berlin, US). The FDA issued a Cleared decision on May 30, 1996 after a review of 213 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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 Taylor Industries, Inc. devices

FDA 510(k) Submission Details - K954951

510(k) Number K954951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1995
Decision Date May 30, 1996
Days to Decision 213 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
65d slower than avg
Panel avg: 148d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 228
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K954951.
SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY
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TRANSAMERICA ELECTRODE
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FOCUS MODEL 795 UNIT
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GALVA 5-T
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EPIX XL TENS UNIT
K951903 · Empi · Mar 1996