# K040400: Myo-Trode SG Disposable Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Myotronics-Noromed, Inc.
- Decided: Jul 20, 2004 after 154 days
- Product code: NUW (Stimulator, Muscle, Powered, Dental)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K842223 (1984). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010431: Lead-Lok Reusable Tens/ Nmes Electrodes, Lead-Lok, Inc. (2001) Summary page 4.
- K961141: Easy Flex Tens/Fes/MNS Electrodes 2 Round Model 8200/2X2 Model 8220, Uni-Patch, Inc. (1996) Summary page 4.
- K921498: Ver Med A10011 PNS Dual Element Electrode, Vermont Medical, Inc. (1993) Summary page 4.
- K842224: BNS 40, Myo-Tronics Research, Inc. (1984) Summary page 4.
- K842223: J4 Myo-Monitor, Myo-Tronics Research, Inc. (1984) Summary page 4.
- K031998: Model J-5 Mvo-Monitor, Myotronics-Noromed, Inc. (2003) Summary page 4.

## Indications for use
As a disposable, adhesive, conductive interface between a patient's skin and muscle stimulating devices manufactured by Myotronics-Noromed, Inc. including the Models 54, JS, and BNS-40.

Source page: https://510kreport.com/device/K040400
Methodology: https://510kreport.com/methodology