Cleared Traditional

K812612 - TNS MK I STIMULATOR

K812612 is the FDA 510(k) clearance for TNS MK I STIMULATOR by Edu Kit , Ltd.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K812612 · Edu Kit , Ltd. · Neurology device
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Feb 1982
Decision
156d
Days
Class 2
Risk

K812612 is an FDA 510(k) clearance for the TNS MK I STIMULATOR. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Edu Kit , Ltd. (Walker, US). The FDA issued a Cleared decision on February 18, 1982 after a review of 156 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 Edu Kit , Ltd. devices

Submission Details

510(k) Number K812612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1981
Decision Date February 18, 1982
Days to Decision 156 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 148d · This submission: 156d
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 140
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K812612.
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K812704 · Medtronic Vascular · Oct 1981
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K810593 · Medical Devices, Inc. · Mar 1981