# K992439: Norodyn 8000 Semg System, ND-8000

- Pathway: 510(k) (Special)
- Applicant: Myotronics-Noromed, Inc.
- Decided: Aug 13, 1999 after 22 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ProComp DSP: named in the summary without a submission number
- (no number) ProComp: named in the summary without a submission number
- (no number) Myosystem 1000 Electromyograph: named in the summary without a submission number
- (no number) I-330 Physiological Monitor: named in the summary without a submission number

## Most influential descendants
- K013399: Model Mes-9000/Emg System (2001), 2 descendants of its own
- 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 patient’s relaxation state

Source page: https://510kreport.com/device/K992439
Methodology: https://510kreport.com/methodology