Cleared Traditional

K790850 - T.E.N.S.* SINGLE-USE ELECTRODE

K790850 is the FDA 510(k) clearance for T.E.N.S.* SINGLE-USE ELECTRODE by 3M Company. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K790850 · 3M Company · Neurology device
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May 1979
Decision
27d
Days
Class 2
Risk

K790850 is an FDA 510(k) clearance for the T.E.N.S.* SINGLE-USE ELECTRODE. 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 31, 1979 after a review of 27 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

Submission Details

510(k) Number K790850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1979
Decision Date May 31, 1979
Days to Decision 27 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
121d faster than avg
Panel avg: 148d · This submission: 27d
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 K790850.
MODEL 3854 ELECTRODE
K820876 · Medtronic Vascular · Apr 1982
MEDTRONIC #3798 ELECTRODE
K812418 · Medtronic Vascular · Sep 1981
MEDTRONIC MOD. 3852 STERIL-ICE ELECTRODE
K792351 · Medtronic Vascular · Dec 1979
MEDTRONIC MODEL 3797 ELECTRODE
K782137 · Medtronic Vascular · Feb 1979
EEG LEAD ASSEMBLY
K781494 · Graphic Controls Corp. · Oct 1978