# K140780: Kegel Smart, Kegelsmart Pearl

- Pathway: 510(k) (Traditional)
- Applicant: Regulatory Insight, Inc.
- Decided: Sep 10, 2014 after 166 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 K934552 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994079: Reflex Treatment System, Deschutes Medical Products, Inc. (2000) Summary page 4.

## Indications for use
The Intimina KegelSmart and Intimina KegelSmart Pearl are intended for independent use by women at home to strengthen pelvic floor muscles to treat stress and/or urge urinary incontinence.

Source page: https://510kreport.com/device/K140780
Methodology: https://510kreport.com/methodology