# K013612: Incare Pelvic Floor Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Mar 19, 2002 after 134 days
- Product code: HIR (Perineometer)
- Device class: 2
- Regulation: 21 CFR 884.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K930530 (1995). 4 ancestors in all.
38 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930530: Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc, Hollister, Inc. (1995) Summary page 1.
- K961872: Incare Pelvic Floor Therapy System with Desktop Computer, Hollister, Inc. (1996) Summary page 1.
- K974048: Incare Pelvic Floor Therapy System with Desktop Computer, Hollister, Inc. (1997) Summary page 1.
- K964738: Elpha 2000 Conti, Dan Med, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K110179: Incontrol (2012), 21 descendants of its own
- K134020: Intonemv (2014), 10 descendants of its own

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

Source page: https://510kreport.com/device/K013612
Methodology: https://510kreport.com/methodology