# K013399: Model Mes-9000/Emg System

- Pathway: 510(k) (Special)
- Applicant: Myotronics-Noromed, Inc.
- Decided: Nov 13, 2001 after 29 days
- Product code: HCC (Device, Biofeedback)
- Device class: 2
- Regulation: 21 CFR 882.5050
- 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 K922838 (1993). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922838: Norodyn 2000 Electromyograph, Noromed, Inc. (1993) Summary page 1.
- K922270: Physiotech 4000 or Norodyn 8000, Myo-Tronics, Inc. (1994) Summary page 1.
- K992439: Norodyn 8000 Semg System, ND-8000, Myotronics-Noromed, Inc. (1999) Summary page 1.

## Most influential descendants
- K111687: Emg System (2011), 0 descendants of its own
- K061828: Lorenz Biotech Aptiva, Version 2.13 (2007), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K013399
Methodology: https://510kreport.com/methodology