510(k) Report

510(k) · Cleared

Cleared

Model Mes-9000/Emg System

K013399510(k) SpecialCleared Nov 13, 200129-day reviewClass II21 CFR 882.5050

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

Myotronics-Noromed, Inc. · HCC Device, Biofeedback

Cleared on Nov 13, 2001 as substantially equivalent to K922838 (Noromed, Inc., 1993) and 2 other predicates after a 29-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.

Decided
Nov 13, 2001
Review
29 days
Class
Class II
Product code
HCC
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K922838 (1993). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1994: 1 other ancestor2011: 1 descendant cleared2007: 1 descendant clearedK922838 · Norodyn 2000 Electromyograph · Noromed, Inc. · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants K922838 · Norodyn 2000 Electromyograph · Noromed, Inc. · 19930
  1. Root · 1 generation backK922838 Norodyn 2000 ElectromyographNoromed, Inc. · 1993
  2. This deviceK013399 Model Mes-9000/Emg SystemMyotronics-Noromed, Inc. · 2001
  3. Descendant · cites it directly · 0 of its ownK111687 Emg SystemMyotronics-Noromed, Inc. · 2011
  4. Descendant · cites it directly · 0 of its ownK061828 Lorenz Biotech Aptiva, Version 2.13Lorenz Biotech S.P.A. · 2007

Most influential descendants

Showing 2 of 2 · See all
  • K111687Emg SystemMyotronics-Noromed, Inc. · 2011 · cites it directly0descendants
  • K061828Lorenz Biotech Aptiva, Version 2.13Lorenz Biotech S.P.A. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K922838Norodyn 2000 ElectromyographNoromed, Inc.1993—
0 (this device)K013399Model Mes-9000/Emg SystemMyotronics-Noromed, Inc.2001—
+1K111687Emg SystemMyotronics-Noromed, Inc.2011—
+1K061828Lorenz Biotech Aptiva, Version 2.13Lorenz Biotech S.P.A.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201110
FIG. 1 — Lineage of K013399, 1993–2011Source: 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 HCC? 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 HCC device

  1. #1 K233580 A Breathing System (ABS)score 8.1 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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
*K922838Norodyn 2000 Electromyograph
Summary page 1
…Fray Adib, President Device: Model MES-9000/EMG System consisting of computer-based surface electromyography (SEMG). Legally marketed predicate devices: Model ND-2000 (K922838A), ND-8000 (K922270 & K992439) Myotronics-Noromed, Inc. Description of the Device: The device incorporates circuitry enabling th…
Noromed, Inc.1993—
*K922270Physiotech 4000 or Norodyn 8000
Summary page 1
…Device: Model MES-9000/EMG System consisting of computer-based surface electromyography (SEMG). Legally marketed predicate devices: Model ND-2000 (K922838A), ND-8000 (K922270 & K992439) Myotronics-Noromed, Inc. Description of the Device: The device incorporates circuitry enabling the capabilities of th…
Myo-Tronics, Inc.1994—
*K992439Norodyn 8000 Semg System, ND-8000
Summary page 1
…Model MES-9000/EMG System consisting of computer-based surface electromyography (SEMG). Legally marketed predicate devices: Model ND-2000 (K922838A), ND-8000 (K922270 & K992439) Myotronics-Noromed, Inc. Description of the Device: The device incorporates circuitry enabling the capabilities of the two pred…
Myotronics-Noromed, Inc.1999—

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111687Emg SystemMyotronics-Noromed, Inc.20110
K061828Lorenz Biotech Aptiva, Version 2.13Lorenz Biotech S.P.A.20070

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K111687 (Myotronics-Noromed, Inc., 2011) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HCC devices

HCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HCC

1in 2024

2007: 12008: 22010: 12011: 12013: 22015: 22017: 12018: 12023: 12024: 1
2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCC

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

Recalls per year · HCC

1in 2015

2012: 12015: 1
2007high 1 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HCC

5in 2024

2007: 22008: 22009: 12011: 42012: 22013: 22014: 22016: 42017: 32018: 12019: 62020: 22022: 32023: 22024: 5
2007high 6 (2019) · low 0 (2010)2025

MAUDE reports naming product code HCC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—02
20082—02
20090—01
20101—00
20111—04
20120—12
20132—02
20140—02
20152—10
20160—04
20171—03
20181—01
20190—06
20200—02
20210—00
20220—03
20231—02
20241—05
20250—00
20260—0—

What is it indicated for?

For evaluation of the status of muscles at rest and in function

As an aid in muscle re-education and muscle relaxation therapy

Provides ability to compare new captured data with past data to assess progress in treating patients relaxation state

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Myotronics-Noromed, Inc.

7 FDA decisions under this applicant name. See the company

  • K111687Emg SystemMyotronics-Noromed, Inc. · 2011
  • K040400Myo-Trode SG Disposable ElectrodeMyotronics-Noromed, Inc. · 2004
  • K031998Model J-5 Mvo-MonitorMyotronics-Noromed, Inc. · 2003
  • K003287Model K7 Evaluation DeviceMyotronics-Noromed, Inc. · 2000
  • K992694Modification to K6-I Diagnostic System, Model K6-IMyotronics-Noromed, Inc. · 1999

Recent decisions in HCC

The HCC category page

  • K233580A Breathing System (ABS)Deepwell Dtx, Inc. · 2024
  • K222101PrismGraymatters Health, Ltd. · 2023
  • K180173FreespiraPalo Alto Health Sciences, Inc. · 2018
  • K163448GrindCare SystemSunstar Suisse S.A. · 2017
  • K151050Pacifier Activated Lullaby (PAL®)Power Medical Devices, LLC · 20151 recall

https://510kreport.com/device/K013399 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013399: Model Mes-9000/Emg System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013399

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026