# K023209: Insight Millennium Iii

- Pathway: 510(k) (Traditional)
- Applicant: Fasstech
- Decided: Oct 10, 2003 after 379 days
- Product code: IKN (Electromyograph, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 890.1375
- 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 K971407 (1998). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011964: Insight Millennium Plus, Fasstech (2001)
- K914925: Medac System/3, Davicon, Inc. (1993) Summary page 3.

## Most influential descendants
- 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
- K033452: CWAS 1000 (2003), 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 ange of Motion of the three spinal regions To measure atient self-reported pressure sensitivity in joints and muscles . To measure Heart Rate To chart patient progress during the course of treatment

Source page: https://510kreport.com/device/K023209
Methodology: https://510kreport.com/methodology