Cleared Traditional

K912381 - LOW BACK STRIP (OR) K-BACK

K912381 is the FDA 510(k) clearance for LOW BACK STRIP (OR) K-BACK by Katecho, Inc.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K912381 · Katecho, Inc. · Neurology device
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Jan 1992
Decision
246d
Days
Class 2
Risk

K912381 is an FDA 510(k) clearance for the LOW BACK STRIP (OR) K-BACK. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Katecho, Inc. (Des Moines, US). The FDA issued a Cleared decision on January 30, 1992 after a review of 246 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 Katecho, Inc. devices

Submission Details

510(k) Number K912381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1991
Decision Date January 30, 1992
Days to Decision 246 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 148d · This submission: 246d
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 K912381.
INTELECT 600MP
K920260 · Chattanooga Group, Inc. · Oct 1992
TEAM-MC II
K921828 · Henley Intl. · Sep 1992
ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A
K915210 · Biomedical Life Systems, Inc. · May 1992
MEDTRONIC MODEL 90002065 MF TENS SYSTEM
K911963 · Medtronic Vascular · Dec 1991
TEAM-MC
K905672 · Henley Intl. · Oct 1991
DYNEX IIIB, MODEL 89002026
K913594 · Medtronic Vascular · Aug 1991