# K941911: Innova Pelvic Floor Stimulation System

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Jan 20, 1995 after 276 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.
20 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K970307: Minnova Pelvic Floor Stimulation System (1997), 12 descendants of its own
- K973096: Neotonus Model 1000 Muscle Stimulator System (1998), 9 descendants of its own
- K162010: HPM-6000U (2016), 7 descendants of its own
- K181497: HPM-6000UF (2018), 6 descendants of its own
- K103698: Tenscare Itouch Sure Model Its (2011), 6 descendants of its own

Source page: https://510kreport.com/device/K941911
Methodology: https://510kreport.com/methodology