Cleared Traditional

LOAD SENTINEL II, TRANS. ELEC. NERVE (K802779) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K802779 · Powers Medical Systmes · Neurology device
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Dec 1980
Decision
36d
Days
Class 2
Risk

K802779 is an FDA 510(k) clearance for the LOAD SENTINEL II, TRANS. ELEC. NERVE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Powers Medical Systmes (Mchenry, US). The FDA issued a Cleared decision on December 10, 1980 after a review of 36 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 Powers Medical Systmes devices

Submission Details

510(k) Number K802779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1980
Decision Date December 10, 1980
Days to Decision 36 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 148d · This submission: 36d
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 39
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K802779.
NEUROMOD COMPLEMENT #7724 DUAL CHANNEL
K823742 · Medtronic Vascular · Jan 1983
NEUROMEDICS ORIONS #660-01
K822600 · Intermedics, Inc. · Sep 1982
NEUROMED SELECTRA #7720
K812704 · Medtronic Vascular · Oct 1981
TENZCARE DUAL-CHANNEL STIMULATOR
K800758 · 3M Company · Apr 1980
MEDTRONIC MODEL 7728 NEUROMOD
K792311 · Medtronic Vascular · Nov 1979
STIMULATOR, MODEL 7727
K782075 · Medtronic Vascular · Dec 1978