# K142506: TensCare KegelFit

- Pathway: 510(k) (Traditional)
- Applicant: Tenscare, Ltd.
- Decided: Apr 20, 2015 after 224 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: 9 generations back to K930530 (1995). 28 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141158: APEX, Incontrol Medical, LLC (2014). Cleared while this submission was under review Summary page 5.
- K103698: Tenscare Itouch Sure Model Its, Tenscare, Ltd. (2011) Summary page 5.

## Most influential descendants
- K191312: Perfect PFE (2019), 3 descendants of its own
- K260178: Pelvic Muscle Trainer (KM510, KM516B) (2026), 0 descendants of its own
- K251760: Well-Life Incontinence Stimulation System (WL-2405i (P)) (2026), 0 descendants of its own
- K230983: Unicare (K-UNICARE-USA) (2023), 0 descendants of its own

## Indications for use
KegelFit is a non-implanted muscle stimulator designed to treat female stress urinary incontinence. It applies stimulation to the pelvic floor muscles to improve strength and support. The KegelFit is intended for OTC sale.

Source page: https://510kreport.com/device/K142506
Methodology: https://510kreport.com/methodology