# K110179: Incontrol

- Pathway: 510(k) (Traditional)
- Applicant: Incontrol Medical, LLC
- Decided: Feb 22, 2012 after 397 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: 7 generations back to K930530 (1995). 24 ancestors in all.
21 later devices descend from it; 7 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080950: Stiwell MED4, Otto Bock, Austria GmbH (2009) Summary page 1.
- K053434: Myotrac Infiniti Electrical Stimulator, Thought Technology, Ltd. (2006) Summary page 1.
- K050483: Evadri Bladder Control Systems, Hollister, Inc. (2005) Summary page 1.

## Most influential descendants
- K134020: Intonemv (2014), 10 descendants of its own
- K141158: APEX (2014), 9 descendants of its own
- K181497: HPM-6000UF (2018), 6 descendants of its own
- K142506: TensCare KegelFit (2015), 4 descendants of its own
- K191312: Perfect PFE (2019), 3 descendants of its own

## Indications for use
The InControl InTone device is a non-implanted electrical stimulator indicated for the treatment of female urinary incontinence. It applies electrical stimulation to the pelvic floor musculature and surrounding structures. It is intended for acute and ongoing treatment of mixed urinary incontinence where the following results may improve urinary control: strengthening of pelvic floor muscles and inhibition of the detrusor muscle through reflexive mechanisms. The biofeedback feature can be used for muscle re-education purposes.

Source page: https://510kreport.com/device/K110179
Methodology: https://510kreport.com/methodology