# K171896: Feminine Personal Trainer (FPT)

- Pathway: 510(k) (Traditional)
- Applicant: Ralston Group
- Decided: Aug 29, 2017 after 64 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.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121902: Natratone, Orelle Corporation, Ltd. (2013) Summary page 4.

## Most influential descendants
- K193364: Intimate Rose Kegel Exercise System (2020), 0 descendants of its own

## Indications for use
The Feminine Personal Trainer (FPT) 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, urinary incontinence in women.

Source page: https://510kreport.com/device/K171896
Methodology: https://510kreport.com/methodology