Cleared Traditional

K961749 - TRANSAMERICA ELECTRODE

K961749 is an FDA 510(k) clearance for TRANSAMERICA ELECTRODE, manufactured by Transamerica Medical Systems. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K961749 · Transamerica Medical Systems · Neurology device
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Jun 1996
Decision
88d
Days
Class 2
Risk

K961749 is an FDA 510(k) clearance for the TRANSAMERICA ELECTRODE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Transamerica Medical Systems (South Hadley, US). The FDA issued a Cleared decision on June 21, 1996 after a review of 88 days - a notably fast clearance 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: 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 Transamerica Medical Systems devices

FDA 510(k) Submission Details - K961749

510(k) Number K961749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1996
Decision Date June 21, 1996
Days to Decision 88 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
60d faster than avg
Panel avg: 148d · This submission: 88d
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 K961749.
SMART-TENS, MODEL 456
K961376 · Bio-Medical Research, Ltd. · Sep 1996
SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY
K962910 · Uni-Patch, Inc. · Sep 1996
TENS/FES/NMES ELECTRODES
K962332 · Uni-Patch, Inc. · Jul 1996
TAYLOR GENERAL PURPOSE MONITORING ELECTRODE
K954951 · Taylor Industries, Inc. · May 1996
FOCUS MODEL 795 UNIT
K951951 · Empi · May 1996
GALVA 5-T
K960969 · Zimmer Elektromedizin GmbH · May 1996