Cleared Traditional

K813569 - EMOTENS

K813569 is the FDA 510(k) clearance for EMOTENS by Electro Medica Office. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K813569 · Electro Medica Office · Neurology device
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Feb 1982
Decision
64d
Days
Class 2
Risk

K813569 is an FDA 510(k) clearance for the EMOTENS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Electro Medica Office (Mchenry, US). The FDA issued a Cleared decision on February 24, 1982 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Electro Medica Office devices

Submission Details

510(k) Number K813569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1981
Decision Date February 24, 1982
Days to Decision 64 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 148d · This submission: 64d
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 K813569.
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NEUROMEDICS ORIONS #660-01
K822600 · Intermedics, Inc. · Sep 1982
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NEUROMED SELECTRA #7720
K812704 · Medtronic Vascular · Oct 1981
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K810593 · Medical Devices, Inc. · Mar 1981