# K160773: Yarlap II

- Pathway: 510(k) (Traditional)
- Applicant: International Trade Group, Inc.
- Decided: May 4, 2016 after 44 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: 6 generations back to K891773 (1989). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141643: Yarlap, International Trade Group, Inc. (2015) Summary page 4.

## Most influential descendants
- 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
- K241862: Levina Pelvic Floor Muscle Stimulator (RS-48) (2025), 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/K160773
Methodology: https://510kreport.com/methodology