# K193364: Intimate Rose Kegel Exercise System

- Pathway: 510(k) (Traditional)
- Applicant: Plus EV Holdings Dba Intimate Rose
- Decided: Aug 24, 2020 after 264 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: 4 generations back to K002830 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171896: Feminine Personal Trainer (FPT), Ralston Group (2017) Summary page 4.

## Indications for use
The Intimate Rose Kegel Exercise System is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, low tone in the pelvic floor, which can cause or contribute to health issues including urinary incontinence and sexual dysfunction.

Source page: https://510kreport.com/device/K193364
Methodology: https://510kreport.com/methodology