Cleared Traditional

K854476 - KALMATE MODEL 3A

K854476 is the FDA 510(k) clearance for KALMATE MODEL 3A by Medical Technology Systems, Inc.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K854476 · Medical Technology Systems, Inc. · Neurology device
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Feb 1986
Decision
112d
Days
Class 2
Risk

K854476 is an FDA 510(k) clearance for the KALMATE MODEL 3A. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Medical Technology Systems, Inc. (San Jose, US). The FDA issued a Cleared decision on February 27, 1986 after a review of 112 days - within the typical 510(k) review window.

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 Medical Technology Systems, Inc. devices

Submission Details

510(k) Number K854476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1985
Decision Date February 27, 1986
Days to Decision 112 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 148d · This submission: 112d
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 K854476.
EMPI MODEL GLS 450, TENS
K861830 · Empi · Jul 1986
EMPI MODEL 720 NMS, TENS
K861451 · Empi · Jul 1986
FASTENS(TM)
K854316 · Medical Devices, Inc. · Feb 1986
MINIPAC PERSONAL TOUCH (TM)
K854761 · Medical Devices, Inc. · Feb 1986
MINIPAC (TM)
K854317 · Medical Devices, Inc. · Jan 1986
SYS STIM 206 MODEL ME206
K851735 · Mettler Electronics Corp. · Nov 1985