# K200409: Pelvital System

- Pathway: 510(k) (Traditional)
- Applicant: Pelvital USA, Inc.
- Decided: Jul 10, 2020 after 142 days
- Product code: HIR (Perineometer)
- Device class: 2
- Regulation: 21 CFR 884.1425
- 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 K002830 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162689: Vibrance Pelvic Trainer, Bioinfinity (M) Sdn. Bhd. (2017) Summary page 5.

## Indications for use
The Pelvital System is intended for the strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence.

Source page: https://510kreport.com/device/K200409
Methodology: https://510kreport.com/methodology