Cleared Traditional

K782164 - STIMULATOR, MODEL 1-600 ELECTRIC NERVR

K782164 is an FDA 510(k) clearance for STIMULATOR, manufactured by Ipco Corp.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K782164 · Ipco Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1979
Decision
76d
Days
Class 2
Risk

K782164 is an FDA 510(k) clearance for the STIMULATOR, MODEL 1-600 ELECTRIC NERVR. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Ipco Corp. (Mchenry, US). The FDA issued a Cleared decision on March 8, 1979 after a review of 76 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.

FDA 510(k) Submission Details - K782164

510(k) Number K782164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1978
Decision Date March 08, 1979
Days to Decision 76 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
73d faster than avg
Panel avg: 149d · This submission: 76d
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 605
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K782164.
NURITE II VRM DUAL (ELEC. NERVE STIM.)
K791834 · Bio-Medical Systems Corp. · Oct 1979
MODEL 810 VERI/TGS
K791187 · Verite · Aug 1979
STIMULATOR, ELECTRICAL NERVE
K791158 · Electreat, Inc. · Jul 1979
STIMULATOR, MENTOR 100 NERVE
K790011 · Mentor Corp. · Mar 1979
ELECTREAT MODEL 250 TRANSCUTANEOUS STIM
K790189 · Electreat, Inc. · Feb 1979
STIMULATOR, ELECTRICAL NERVE
K782127 · Somatronics, Inc. · Jan 1979
K782164 · STIMULATOR, MODEL 1-600 ELECTRIC NERVR
Download PDF Ipco Corp.