510(k) Report

510(k) · Cleared

Cleared

Myo-Trode SG Disposable Electrode

K040400510(k) TraditionalCleared Jul 20, 2004154-day reviewClass II21 CFR 890.5850

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Myotronics-Noromed, Inc. · NUW Stimulator, Muscle, Powered, Dental

Cleared on Jul 20, 2004 as substantially equivalent to K010431 (Lead-Lok, Inc., 2001) and 5 other predicates after a 154-day review. Its family tree reaches back 2 generations to 1984.

Decided
Jul 20, 2004
Review
154 days
Class
Class II
Product code
NUW
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K842223 (1984). 6 ancestors in all, the oldest K842224 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1996: 1 other ancestor1993: 1 other ancestor1984: 1 other ancestorK842223 · J4 Myo-Monitor · Myo-Tronics Research, Inc. · 1984K031998 · Model J-5 Mvo-Monitor · Myotronics-Noromed, Inc. · 2003198019851990199520002005
Other ancestors, by generation 1 generation back: 4 other ancestors K031998 · Model J-5 Mvo-Monitor · Myotronics-Noromed, Inc. · 2003K842223 · J4 Myo-Monitor · Myo-Tronics Research, Inc. · 19840
  1. Root · 2 generations backK842223 J4 Myo-MonitorMyo-Tronics Research, Inc. · 1984
  2. 1 generation backK031998 Model J-5 Mvo-MonitorMyotronics-Noromed, Inc. · 2003
  3. This deviceK040400 Myo-Trode SG Disposable ElectrodeMyotronics-Noromed, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K842223J4 Myo-MonitorMyo-Tronics Research, Inc.1984—
−1K031998Model J-5 Mvo-MonitorMyotronics-Noromed, Inc.2003—
0 (this device)K040400Myo-Trode SG Disposable ElectrodeMyotronics-Noromed, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199310
199610
200110
FIG. 1 — Lineage of K040400, 1984–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NUW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NUW device

  1. #1 K243290 BTL-785MJscore 9.9 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K010431Lead-Lok Reusable Tens/ Nmes Electrodes
Summary page 4
…ding the Models J4, J5, and BNS-40. Comparison with equivalent devices: The device is virtually identical to several devices that have previously been legally marketed. K010431 and K961141 (as above) are given as specific examples. Safety & Effectiveness Information: There are no significant differences…
Lead-Lok, Inc.2001—
*K961141Easy Flex Tens/Fes/MNS Electrodes 2 Round Model 8200/2X2 Model 8220
Summary page 4
…on: Unclassified, Product code KZM Predicate devices: Lead-Lok neurostimulation electrodes, KO 10431, Uni-Patch TENS Electrodes, K961141, Myotrodes II, K921498, Model BNS-40, K842224/A, Model J-4, K842223, Model J-5,…
Uni-Patch, Inc.1996—
*K921498Ver Med A10011 PNS Dual Element Electrode
Summary page 4
…ed, Product code KZM Predicate devices: Lead-Lok neurostimulation electrodes, KO 10431, Uni-Patch TENS Electrodes, K961141, Myotrodes II, K921498, Model BNS-40, K842224/A, Model J-4, K842223, Model J-5, K03 1998 Description…
Vermont Medical, Inc.1993—
*K842224BNS 40
Summary page 4
…ead-Lok neurostimulation electrodes, KO 10431, Uni-Patch TENS Electrodes, K961141, Myotrodes II, K921498, Model BNS-40, K842224/A, Model J-4, K842223, Model J-5, K03 1998 Description of the Device: A disposable cutaneous TENS stimu…
Myo-Tronics Research, Inc.1984—
*K842223J4 Myo-Monitor
Summary page 4
…on electrodes, KO 10431, Uni-Patch TENS Electrodes, K961141, Myotrodes II, K921498, Model BNS-40, K842224/A, Model J-4, K842223, Model J-5, K03 1998 Description of the Device: A disposable cutaneous TENS stimulating electrode consi…
Myo-Tronics Research, Inc.1984—
*K031998Model J-5 Mvo-Monitor
Summary page 4
…Uni-Patch TENS Electrodes, K961141, Myotrodes II, K921498, Model BNS-40, K842224/A, Model J-4, K842223, Model J-5, K03 1998 Description of the Device: A disposable cutaneous TENS stimulating electrode consisting of a metal snap connector, adhesive foam…
Myotronics-Noromed, Inc.2003—

Also cleared against K010431: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 18.7 years on median.
  • None of the 6 ancestors has a recall.
  • 3 other devices also cite its predicate K010431.

How does its category compare?

All NUW devices

NUW Stimulator, Muscle, Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NUW

1in 2025

2021: 12025: 1
2007high 1 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NUW

Too few NUW 510(k)s in any year since 2007 to give a median.

Recalls per year · NUW

No recall names NUW since 2007.

Adverse event reports per year · NUW

No MAUDE report names NUW since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20211—00
20220—00
20230—00
20240—00
20251—00
20260—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Also cleared against K010431

3 other devices cite the same predicate.

  • K121816Sensus ElectrodeNeurometrix, Inc. · 2012
  • K070807Cutaneous Electrotherapy and Recording Electrodes; Tens ElectrodesPepin Mfg., Inc. · 2007
  • K052875Prostim Reusable Neurostimulation ElectrodesSummit Manufacturing, LLC · 2005

More from Myotronics-Noromed, Inc.

7 FDA decisions under this applicant name. See the company

  • K111687Emg SystemMyotronics-Noromed, Inc. · 2011
  • K031998Model J-5 Mvo-MonitorMyotronics-Noromed, Inc. · 2003
  • K013399Model Mes-9000/Emg SystemMyotronics-Noromed, Inc. · 2001
  • K003287Model K7 Evaluation DeviceMyotronics-Noromed, Inc. · 2000
  • K992694Modification to K6-I Diagnostic System, Model K6-IMyotronics-Noromed, Inc. · 1999

Recent decisions in NUW

The NUW category page

  • K243290BTL-785MJBTL Industries, Inc. · 2025
  • K203525D functionIto Co., Ltd. · 2021
  • K031998Model J-5 Mvo-MonitorMyotronics-Noromed, Inc. · 2003
  • K901902Acusource 600 for Use with TMJ ElectrodeMicrocurrent Research, Inc. · 1990
  • K890143Acutron Multiwave for Use in TMJ Syndrome Pain ConMicrocurrent Research, Inc. · 1989

https://510kreport.com/device/K040400 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040400: Myo-Trode SG Disposable Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040400

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026