Cleared Traditional

K962910 - SPEC T.E.N.S. PREWIRED REPOSITIONABLE T...

K962910 is the FDA 510(k) clearance for SPEC T.E.N.S. PREWIRED REPOSITIONABLE T... by Uni-Patch, Inc.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K962910 · Uni-Patch, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
62d
Days
Class 2
Risk

K962910 is an FDA 510(k) clearance for the SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Uni-Patch, Inc. (Wabasha, US). The FDA issued a Cleared decision on September 5, 1996 after a review of 62 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 Uni-Patch, Inc. devices

Submission Details

510(k) Number K962910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1996
Decision Date September 05, 1996
Days to Decision 62 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
86d faster than avg
Panel avg: 148d · This submission: 62d
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 129
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K962910.
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K935324 · Chattanooga Group, Inc. · May 1994