# K011964: Insight Millennium Plus

- Pathway: 510(k) (Traditional)
- Applicant: Fasstech
- Decided: Sep 20, 2001 after 87 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 K971407 (1998). 2 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K990778: Insight Millennium, Fasstech (1999) Summary page 3.
- K971407: Jtech Commander and Algometer, J-Tech Medical, Inc. (1998) Summary page 3.

## Most influential descendants
- 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
- 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 Range of Motion of the three spinal regions To measure patient self-reported pressure sensitivity in joints and muscles To chart patient progress during the course of treatment

Source page: https://510kreport.com/device/K011964
Methodology: https://510kreport.com/methodology