# K963236: M & R Disposable Electrode (14200)

- Pathway: 510(k) (Traditional)
- Applicant: M & R Mfg., Inc.
- Decided: Nov 15, 1996 after 88 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K851303 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851303: Comfort-Ease Electrode, Medtronic Vascular (1985) Summary page 2.
- K911366: Protector Disposable Tens and Nmes Electrode, Medical Design & Manufacturing Corp. (1991) Summary page 2.

## Indications for use
M&R Disposable Electrodes are intended for single-patient/single-application use in TENS (“traditional” TENS, microcurrent TENS, etc.) and NMES (“traditional” NMES, interferential NMES, high-volt pulsed galvanic NMES, functional electrical stimulation (FES), etc.) applications.

Source page: https://510kreport.com/device/K963236
Methodology: https://510kreport.com/methodology