# K252748: Pelvic Floor Exerciser (PF01)

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Accurate Bio-Medical Technology Co., Ltd.
- Decided: Apr 27, 2026 after 241 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: 5 generations back to K002617 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231780: Perifit Care+, X6 Innovations (2023) Summary page 5.

## Indications for use
The Pelvic Floor Exerciser 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. Pelvic Floor Exerciser is indicated for an adult female.

Source page: https://510kreport.com/device/K252748
Methodology: https://510kreport.com/methodology