# K083679: Uroval BRS System, Model BRS01; Telesis, Model PROMO1

- Pathway: 510(k) (Traditional)
- Applicant: Uroval
- Decided: Sep 11, 2009 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: 1 generation back to K000220 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000220: MA-300 Electromyography System, Motion Lab Systems, Inc. (2000) Summary page 1.
- K001515: Pathway CTS 2000 Pelvic Floor Training System, Model Pathway CTS 2000, The Prometheus Group (2000)

## Indications for use
To acquire EMG signals for display and analysis by, or under the direction of a health care professional, to assess neurogenic sacral dysfunction such as urinary incontinence and fecal incontinence.

Source page: https://510kreport.com/device/K083679
Methodology: https://510kreport.com/methodology