Cleared Traditional

K931570 - COM-TENS (SINGLE MODE)

K931570 is the FDA 510(k) clearance for COM-TENS (SINGLE MODE) by Ems Dist.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K931570 · Ems Dist. · Neurology device
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Jun 1993
Decision
80d
Days
Class 2
Risk

K931570 is an FDA 510(k) clearance for the COM-TENS (SINGLE MODE). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Ems Dist. (Pen Valley, US). The FDA issued a Cleared decision on June 18, 1993 after a review of 80 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 Ems Dist. devices

Submission Details

510(k) Number K931570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1993
Decision Date June 18, 1993
Days to Decision 80 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 148d · This submission: 80d
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
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