# K121902: Natratone

- Pathway: 510(k) (Traditional)
- Applicant: Orelle Corporation, Ltd.
- Decided: Jun 6, 2013 after 342 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.
2 later devices descend 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)
- K021115: Gyneflex, Naissance Holdings, LC (2002) Summary page 1.

## Most influential descendants
- K171896: Feminine Personal Trainer (FPT) (2017), 1 descendant of its own
- K193364: Intimate Rose Kegel Exercise System (2020), 0 descendants of its own

## Indications for use
NatraTone® 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/K121902
Methodology: https://510kreport.com/methodology