# K231780: Perifit Care+

- Pathway: 510(k) (Traditional)
- Applicant: X6 Innovations
- Decided: Dec 20, 2023 after 187 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 K002617 (2001). 4 ancestors in all.
1 later device descends from it; 1 cites 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)
- K221476: Perifit, X6 Innovations (2023) Summary page 5.

## Most influential descendants
- K252748: Pelvic Floor Exerciser (PF01) (2026), 0 descendants of its own

## Indications for use
The Perifit Care+ is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology. Perifit Care+ is indicated for an adult female.

Source page: https://510kreport.com/device/K231780
Methodology: https://510kreport.com/methodology