# K974048: Incare Pelvic Floor Therapy System with Desktop Computer

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Dec 23, 1997 after 60 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: 2 generations back to K930530 (1995). 2 ancestors in all.
42 later devices descend from it; 5 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961872: Incare Pelvic Floor Therapy System with Desktop Computer, Hollister, Inc. (1996) Summary page 1.

## Most influential descendants
- K023906: Pathway CTS2000 Pelvic Floor Training System (2003), 39 descendants of its own
- K013612: Incare Pelvic Floor Therapy System (2002), 38 descendants of its own
- K050483: Evadri Bladder Control Systems (2005), 37 descendants of its own
- K053434: Myotrac Infiniti Electrical Stimulator (2006), 36 descendants of its own
- K080950: Stiwell MED4 (2009), 34 descendants of its own

## Indications for use
The biofeedback components of the InCare Pelvic Floor Therapy System with Desktop Computer are intended to provide electromyographic or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence. The electrical stimulation component of the InCare Pelvic Floor Therapy System with Desktop Computer provides stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

Source page: https://510kreport.com/device/K974048
Methodology: https://510kreport.com/methodology