# K143580: PeriCoach

- Pathway: 510(k) (Traditional)
- Applicant: Analytica, Ltd.
- Decided: Mar 18, 2015 after 90 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 K002617 (2001). 1 ancestor in all.
4 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)
- K002617: Periform Perineometric Probe, Model 8300, Neen Design, Ltd. (2001) Summary page 4.

## Most influential descendants
- K160758: PeriCoach OTC (2016), 3 descendants of its own
- K221476: Perifit (2023), 2 descendants of its own
- K231780: Perifit Care+ (2023), 1 descendant of its own
- K252748: Pelvic Floor Exerciser (PF01) (2026), 0 descendants of its own

## Indications for use
The PeriCoach 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.

Source page: https://510kreport.com/device/K143580
Methodology: https://510kreport.com/methodology