Cleared Traditional

K792522 - MODEL 980D TENS NEUROPACER

K792522 is the FDA 510(k) clearance for MODEL 980D TENS NEUROPACER by Empi. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K792522 · Empi · Neurology device
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Dec 1979
Decision
7d
Days
Class 2
Risk

K792522 is an FDA 510(k) clearance for the MODEL 980D TENS NEUROPACER. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Empi (Mchenry, US). The FDA issued a Cleared decision on December 13, 1979 after a review of 7 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 Empi devices

Submission Details

510(k) Number K792522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1979
Decision Date December 13, 1979
Days to Decision 7 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d faster than avg
Panel avg: 148d · This submission: 7d
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 94
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K792522.
TENSMATE EMPIMODEL 9980
K802507 · Empi · Dec 1980
EMPI MODEL 910S, TENS
K801112 · Empi · May 1980
TENZCARE DUAL-CHANNEL STIMULATOR
K800758 · 3M Company · Apr 1980
MEDTRONIC MODEL 7728 NEUROMOD
K792311 · Medtronic Vascular · Nov 1979
STIMULATOR, MENTOR 100 NERVE
K790011 · Mentor Corp. · Mar 1979
STIMULATOR, MODEL 7727
K782075 · Medtronic Vascular · Dec 1978