# K964738: Elpha 2000 Conti

- Pathway: 510(k) (Traditional)
- Applicant: Dan Med, Inc.
- Decided: Aug 14, 1997 after 274 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
No predicates in its family tree.
40 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

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

## Indications for use
Electrical stimulation of the pelvic floor muscles with the use of vaginal probe. The effect is strengthening the pelvic floor muscles and an activation of the central nervous system. Electrical stimulation of the pelvic floor muscles can reduce urinary incontinence among stress and urge incontinent adult females.

Source page: https://510kreport.com/device/K964738
Methodology: https://510kreport.com/methodology