Cleared Traditional

K831104 - TENZCARE MUSCLE STIMULATION ELECTRODES

K831104 is an FDA 510(k) clearance for TENZCARE MUSCLE STIMULATION ELECTRODES, manufactured by 3M Company. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K831104 · 3M Company · Neurology device
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May 1983
Decision
34d
Days
Class 2
Risk

K831104 is an FDA 510(k) clearance for the TENZCARE MUSCLE STIMULATION ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on May 9, 1983 after a review of 34 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 3M Company devices

FDA 510(k) Submission Details - K831104

510(k) Number K831104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1983
Decision Date May 09, 1983
Days to Decision 34 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
114d faster than avg
Panel avg: 148d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

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 290
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K831104.
CANMED 103
K844098 · Medtronic Vascular · Feb 1985
CANMED 103 9300 ELECTRODE
K844097 · Medtronic Vascular · Dec 1984
NEURO EASE
K831785 · Andover Medical, Inc. · Jun 1983
ELECTRODE 3799
K831046 · Medtronic Vascular · Apr 1983
STERILE SURGICAL PAIN RELIEF ELECTRODE
K830798 · Lectec Corp. · Apr 1983
EMPI SINGLE USE
K822224 · Empi · Aug 1982