# K141643: Yarlap

- Pathway: 510(k) (Traditional)
- Applicant: International Trade Group, Inc.
- Decided: Apr 24, 2015 after 309 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: 5 generations back to K891773 (1989). 11 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081480: KEGEL8 Pelvic Exerciser, Model Oph 400, Ne Services, Ltd. (2008) Summary page 6.
- K083704: Nutrac Pelvator, Model Pel 200, Verity Scientific, Ltd. (2009) Summary page 6.

## Most influential descendants
- K191312: Perfect PFE (2019), 3 descendants of its own
- K160773: Yarlap II (2016), 2 descendants of its own
- K260178: Pelvic Muscle Trainer (KM510, KM516B) (2026), 0 descendants of its own
- K252601: Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) (2026), 0 descendants of its own
- K252552: Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) (2026), 0 descendants of its own

## Indications for use
The device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

Source page: https://510kreport.com/device/K141643
Methodology: https://510kreport.com/methodology