Cleared Traditional

K781829 - NEUROPAC ULTRA II

K781829 is an FDA 510(k) clearance for NEUROPAC ULTRA II, manufactured by Medical Devices, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K781829 · Medical Devices, Inc. · Neurology device
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Nov 1978
Decision
23d
Days
Class 2
Risk

K781829 is an FDA 510(k) clearance for the NEUROPAC ULTRA II. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Medical Devices, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1978 after a review of 23 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 Medical Devices, Inc. devices

FDA 510(k) Submission Details - K781829

510(k) Number K781829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1978
Decision Date November 22, 1978
Days to Decision 23 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
125d faster than avg
Panel avg: 148d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

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
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K781829.
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
NEUROMOD STIMULATOR MODEL 3723
K780186 · Medtronic Vascular · Mar 1978
IMPORTED PAIN CONTROL DEVICE
K771885 · Empi · Nov 1977
ANODYNE II-ELECTRICAL NEURO STIMULATOR
K761053 · Rich-Mar Corp. · Nov 1976