# K111687: Emg System

- Pathway: 510(k) (Special)
- Applicant: Myotronics-Noromed, Inc.
- Decided: Sep 29, 2011 after 105 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: 2 generations back to K922838 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013399: Model Mes-9000/Emg System, Myotronics-Noromed, Inc. (2001) Summary page 1.

## 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/K111687
Methodology: https://510kreport.com/methodology