# K163288: Pelvifine Pelvic Muscle Trainer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Konmed Technology Co., Ltd.
- Decided: Jan 18, 2018 after 422 days
- Product code: KPI (Stimulator, Electrical, Non-Implantable, For Incontinence)
- Device class: 2
- Regulation: 21 CFR 876.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K930530 (1995). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110179: Incontrol, Incontrol Medical, LLC (2012) Summary page 4.
- K141643: Yarlap, International Trade Group, Inc. (2015) Summary page 4.
- K150183: ApexM, Incontrol Medical, LLC (2015) Summary page 4.

## Indications for use
The Pelvifine Pelvic Muscle Trainer (Model: KM518) is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.

Source page: https://510kreport.com/device/K163288
Methodology: https://510kreport.com/methodology