Cleared Traditional

K914871 - TRANS ELEC NERVE STIM/MUSCLE STIM ELEC ...

K914871 is the FDA 510(k) clearance for TRANS ELEC NERVE STIM/MUSCLE STIM ELEC ... by Labeltape Meditect, Inc.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K914871 · Labeltape Meditect, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Dec 1991
Decision
50d
Days
Class 2
Risk

K914871 is an FDA 510(k) clearance for the TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Labeltape Meditect, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on December 18, 1991 after a review of 50 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 Labeltape Meditect, Inc. devices

Submission Details

510(k) Number K914871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1991
Decision Date December 18, 1991
Days to Decision 50 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 148d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 128
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K914871.
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TEAM-MC
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DYNEX IIIB, MODEL 89002026
K913594 · Medtronic Vascular · Aug 1991