Cleared Traditional

K830992 - XCEL MODEL XE-1

K830992 is an FDA 510(k) clearance for XCEL MODEL XE-1, manufactured by Electrocaine Medical System. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K830992 · Electrocaine Medical System · Neurology device
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Aug 1983
Decision
136d
Days
Class 2
Risk

K830992 is an FDA 510(k) clearance for the XCEL MODEL XE-1. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Electrocaine Medical System (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 136 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 Electrocaine Medical System devices

FDA 510(k) Submission Details - K830992

510(k) Number K830992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1983
Decision Date August 12, 1983
Days to Decision 136 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 148d · This submission: 136d
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 292
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K830992.
OBSTETRIC PULSAR TWO CHANNEL TENS
K840497 · Spembly Medical , Ltd. · Apr 1984
EMPI MODEL 984 BASIX, TENS
K841045 · Empi · Apr 1984
NEUROMOD COMFORT WAVE #7721 DUAL-
K832238 · Medtronic Vascular · Aug 1983
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