# K221476: Perifit

- Pathway: 510(k) (Traditional)
- Applicant: X6 Innovations
- Decided: Feb 10, 2023 after 266 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 K002617 (2001). 3 ancestors in all.
2 later devices descend 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)
- K160758: PeriCoach OTC, Analytica, Ltd. (2016) Summary page 4.

## Most influential descendants
- K231780: Perifit Care+ (2023), 1 descendant of its own
- K252748: Pelvic Floor Exerciser (PF01) (2026), 0 descendants of its own

## Indications for use
The Perifit 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 is indicated for an adult female.

Source page: https://510kreport.com/device/K221476
Methodology: https://510kreport.com/methodology