# K990778: Insight Millennium

- Pathway: 510(k) (Traditional)
- Applicant: Fasstech
- Decided: Jun 3, 1999 after 86 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K011964: Insight Millennium Plus (2001), 5 descendants of its own
- K023209: Insight Millennium Iii (2003), 4 descendants of its own
- K063447: Insight Discovery (2007), 1 descendant of its own
- K131094: Vimove (2014), 0 descendants of its own
- K123399: Myovision 3.0 Wirefree System (2013), 0 descendants of its own

## Indications for use
To measure bilateral differences in surface EMG along the spine To measure surface EMG along the spine during functional tasks To measure bilateral differences in skin temperature along the spine To measure Range of Motion of the three spinal regions To chart patient progress during the course of treatment

Source page: https://510kreport.com/device/K990778
Methodology: https://510kreport.com/methodology