# K162689: Vibrance Pelvic Trainer

- Pathway: 510(k) (Traditional)
- Applicant: Bioinfinity (M) Sdn. Bhd.
- Decided: Jun 8, 2017 after 254 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: 2 generations back to K002830 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141893: Vibrance Kegel Device (VKD), Bioinfinity (M) Sdn. Bhd. (2014) Summary page 5.

## Most influential descendants
- K200409: Pelvital System (2020), 0 descendants of its own

## Indications for use
The Vibrance® Pelvic Trainer is intended for the strengthening of the pelvic floor muscles, which has been found to help women with urinary incontinence.

Source page: https://510kreport.com/device/K162689
Methodology: https://510kreport.com/methodology