Cleared Traditional

K864370 - DYNATRON 1120 EPS (ELECTRICAL POINT STI...

K864370 is the FDA 510(k) clearance for DYNATRON 1120 EPS (ELECTRICAL POINT STI... by Dynatronics Laser Corp.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K864370 · Dynatronics Laser Corp. · Neurology device
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Apr 1987
Decision
156d
Days
Class 2
Risk

K864370 is an FDA 510(k) clearance for the DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Dynatronics Laser Corp. (Salt Lake City, US). The FDA issued a Cleared decision on April 10, 1987 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 Dynatronics Laser Corp. devices

Submission Details

510(k) Number K864370 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 05, 1986
Decision Date April 10, 1987
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 128
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K864370.
ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C
K871126 · Biomedical Life Systems, Inc. · Jun 1987
OMEGA T100
K870666 · Henley Intl. · Apr 1987
OMEGA T200
K870667 · Henley Intl. · Apr 1987
EMPI LOGIX MODEL 712 NMS, TENS
K870168 · Empi · Apr 1987
BACPAC (TM), MODEL 6500
K864968 · Medical Devices, Inc. · Mar 1987
ECLIPSE+, MODEL NUMBER 7723
K865048 · Medtronic Vascular · Feb 1987