Cleared Traditional

K893793 - TENZCARE ELECTRODE 6862

K893793 is the FDA 510(k) clearance for TENZCARE ELECTRODE 6862 by 3M Company. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K893793 · 3M Company · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1989
Decision
189d
Days
Class 2
Risk

K893793 is an FDA 510(k) clearance for the TENZCARE ELECTRODE 6862. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on November 27, 1989 after a review of 189 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 3M Company devices

Submission Details

510(k) Number K893793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1989
Decision Date November 27, 1989
Days to Decision 189 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
41d slower than avg
Panel avg: 148d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 141
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K893793.
MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE
K901102 · Empi · Mar 1990
MODIFIED ISLAND SNAP TENS DISPOSABLE ELECTRODE
K901103 · Empi · Mar 1990
MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN
K896485 · Empi · Dec 1989
PROMONTORY STIMULATING ELECTRODE
K895081 · Cadwell Laboratories, Inc. · Nov 1989
EMPI ISLAND TENS ELECTRODE
K890605 · Empi · Mar 1989
EMPI MULTIDAY TENS DISPOSABLE ELECTRODE
K890614 · Empi · Mar 1989