# K103698: Tenscare Itouch Sure Model Its

- Pathway: 510(k) (Traditional)
- Applicant: Tenscare, Ltd.
- Decided: Jun 21, 2011 after 183 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: 1 generation back to K941911 (1995). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941911: Innova Pelvic Floor Stimulation System, Empi (1995) Summary page 1.

## Cited in the summary but kept off the family tree
- K81480: Kegel 8 Pelvic Muscle Trainer. Number could not be read Summary page 1.

## Most influential descendants
- K142506: TensCare KegelFit (2015), 4 descendants of its own
- 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
The itouch Sure 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/K103698
Methodology: https://510kreport.com/methodology