# K081480: KEGEL8 Pelvic Exerciser, Model Oph 400

- Pathway: 510(k) (Traditional)
- Applicant: Ne Services, Ltd.
- Decided: Sep 12, 2008 after 108 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: 4 generations back to K891773 (1989). 9 ancestors in all.
12 later devices descend from it; 3 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)
- K033256: Athena Pelvic Muscle Trainer II, Athena Feminine Technologies, Inc. (2003) Summary page 1.

## Most influential descendants
- K141643: Yarlap (2015), 10 descendants of its own
- 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

## Indications for use
The 'Kegel8' Pelvic Muscle Trainer 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

Source page: https://510kreport.com/device/K081480
Methodology: https://510kreport.com/methodology