# K011983: Insight Genesis

- Pathway: 510(k) (Traditional)
- Applicant: Fasstech
- Decided: Aug 30, 2001 after 65 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 K990778 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990778: Insight Millennium, Fasstech (1999) Summary page 3.

## Indications for use
To measure bilateral differences in surface EMG along the spine To measure surface EMG along the spine during functional tasks To chart patient progress during the course of treatment

Source page: https://510kreport.com/device/K011983
Methodology: https://510kreport.com/methodology