Cleared Traditional

K780444 - NERVTRON-RX

K780444 is the FDA 510(k) clearance for NERVTRON-RX by Medix Corp.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K780444 · Medix Corp. · Neurology device
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Apr 1978
Decision
30d
Days
Class 2
Risk

K780444 is an FDA 510(k) clearance for the NERVTRON-RX. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Medix Corp. (Mchenry, US). The FDA issued a Cleared decision on April 19, 1978 after a review of 30 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 Medix Corp. devices

Submission Details

510(k) Number K780444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1978
Decision Date April 19, 1978
Days to Decision 30 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
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.