# K063447: Insight Discovery

- Pathway: 510(k) (Traditional)
- Applicant: Fasstech
- Decided: Aug 16, 2007 after 274 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: 3 generations back to K971407 (1998). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023209: Insight Millennium Iii, Fasstech (2003) Summary page 3.

## Most influential descendants
- K131094: Vimove (2014), 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 measure Heart Rate To chart patient progress during the course of treatment

Source page: https://510kreport.com/device/K063447
Methodology: https://510kreport.com/methodology