# K021115: Gyneflex

- Pathway: 510(k) (Traditional)
- Applicant: Naissance Holdings, LC
- Decided: Dec 20, 2002 after 256 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: 1 generation back to K002830 (2000). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002830: Pelvic Muscle Therapy, Colonial Medical Supply (2000) Summary page 1.

## Most influential descendants
- K121902: Natratone (2013), 2 descendants of its own
- K171896: Feminine Personal Trainer (FPT) (2017), 1 descendant of its own
- K193364: Intimate Rose Kegel Exercise System (2020), 0 descendants of its own
- K122800: Inner Peace (2013), 0 descendants of its own

## Indications for use
The GyneFlex is recommended for the strengthening of the perineal pelvic floor muscles by offering resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence

Source page: https://510kreport.com/device/K021115
Methodology: https://510kreport.com/methodology