Cleared Traditional

K840098 - MODEL 811 VERI/TENS & PO

K840098 is the FDA 510(k) clearance for MODEL 811 VERI/TENS & PO by Verite. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K840098 · Verite · Neurology device
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Jul 1984
Decision
189d
Days
Class 2
Risk

K840098 is an FDA 510(k) clearance for the MODEL 811 VERI/TENS & PO. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Verite (Mchenry, US). The FDA issued a Cleared decision on July 17, 1984 after a review of 189 days - an extended review 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: 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 Verite devices

Submission Details

510(k) Number K840098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1984
Decision Date July 17, 1984
Days to Decision 189 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 148d · This submission: 189d
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 135
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K840098.
STIMTECH SD PATIENT 6089 #78-8050
K844213 · Codman & Shurtleff, Inc. · Jan 1985
ELECTRO-NERVE STIMULATOR HL
K841184 · Biomedical Life Systems, Inc. · Oct 1984
MENTOR 150 PLUS TRANSCUTANEOUS ELEC.
K842812 · Mentor Corp. · Aug 1984
SD PLUS PATIENT CAT.#78-8010
K840963 · Codman & Shurtleff, Inc. · Apr 1984
SD PLUS CLINICIAN CAT# 78-8015
K840964 · Codman & Shurtleff, Inc. · Apr 1984
EMPI MODEL 984 BASIX, TENS
K841045 · Empi · Apr 1984