Cleared Traditional

K831147 - OMNIPROBE ELECTRICAL NERVE STIMULATOR

K831147 is an FDA 510(k) clearance for OMNIPROBE ELECTRICAL NERVE STIMULATOR, manufactured by Omni Intl., Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K831147 · Omni Intl., Inc. · Neurology device
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Jul 1983
Decision
101d
Days
Class 2
Risk

K831147 is an FDA 510(k) clearance for the OMNIPROBE ELECTRICAL NERVE STIMULATOR. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Omni Intl., Inc. (Walker, US). The FDA issued a Cleared decision on July 18, 1983 after a review of 101 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 Omni Intl., Inc. devices

FDA 510(k) Submission Details - K831147

510(k) Number K831147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1983
Decision Date July 18, 1983
Days to Decision 101 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 148d · This submission: 101d
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 188
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K831147.
EMPI MODEL 984 BASIX, TENS
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PULSAR #B SINGLE CHANNEL TENS-PULSAR D
K831950 · Spembly Medical , Ltd. · Aug 1983
SPEC IISX
K831413 · Medical Devices, Inc. · Jun 1983
NEUROMOD COMPLEMENT #7724 DUAL CHANNEL
K823742 · Medtronic Vascular · Jan 1983
WRIGHT CARE
K823497 · Dow Corning Wright · Jan 1983