# K033452: CWAS 1000

- Pathway: 510(k) (Traditional)
- Applicant: Fasstech
- Decided: Nov 28, 2003 after 29 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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)
- K914920: Biofeedback System/3, Davicon, Inc. (1992) Summary page 2.
- K963271: Futrex-6100/XL, Futrex, Inc. (1998) Summary page 2.

## Indications for use
The CWAS 100 is a non-invasive, multi-modality physiologic monitoring device. The device measures several physiologic signals, and its software generates a report. The CWAS 100 measures the following physiologic signals: Bilateral differences in surface EMG along the spine Heart Rate Skin temperature Galvanic Skin Resistance Body fat percentage in subjects eighteen years and older

Source page: https://510kreport.com/device/K033452
Methodology: https://510kreport.com/methodology