Cleared Traditional

K912381 - LOW BACK STRIP (OR) K-BACK

K912381 is an FDA 510(k) clearance for LOW BACK STRIP (OR) K-BACK, manufactured by Katecho, Inc.. The device is a Class 2 Neurology device with 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.

FDA 510(k) Submission Details - K912381

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 149d · This submission: 246d
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 605
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K912381.
MED-TENS
K921813 · Ems Dist. · Sep 1992
TENS
K921110 · Staodyne, Inc. · Aug 1992
ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A
K915210 · Biomedical Life Systems, Inc. · May 1992
EXCEL MODEL 2110
K910727 · Excel Medical Systems, Inc. · Jan 1992
THERASTIM
K914813 · Precision Electronics , Ltd. · Dec 1991
TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL
K914871 · Labeltape Meditect, Inc. · Dec 1991
K912381 · LOW BACK STRIP (OR) K-BACK
Download PDF Katecho, Inc.