Cleared Traditional

ELECTRO-ACUSCOPE (K832442) - FDA 510(k) Clearance

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

K832442 · Kenneth J. Purcell · Neurology device
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Oct 1983
Decision
98d
Days
Class 2
Risk

K832442 is an FDA 510(k) clearance for the ELECTRO-ACUSCOPE. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Kenneth J. Purcell (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kenneth J. Purcell devices

Submission Details

510(k) Number K832442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1983
Decision Date October 31, 1983
Days to Decision 98 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 148d · This submission: 98d
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 K832442.
CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.
K863469 · Cordis Corp. · Feb 1987
TENSMED II
K851063 · Intermedics, Inc. · Jun 1985
INTERCEPTOR, 662-01
K844279 · Intermedics, Inc. · Jan 1985
NEUROMOD COMFORT WAVE #7721 DUAL-
K832238 · Medtronic Vascular · Aug 1983
NEUROMOD COMPLEMENT #7724 DUAL CHANNEL
K823742 · Medtronic Vascular · Jan 1983
NEUROMEDICS ORIONS #660-01
K822600 · Intermedics, Inc. · Sep 1982