# K964577: Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small Vaginal Electrode (199205)

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Jan 24, 1997 after 71 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 K891773 (1989). 5 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910081: TBD, Empi (1991) Summary page 1.
- K940091: Innova Vaginal Emg Sensing Electrode, Empi (1994) Summary page 1.
- K952688: Innova Rectal or Small Vaginal Emg Sensing Electrode, Empi (1995) Summary page 1.
- K954272: Innova Rectal Stimulaton Electrode, Empi (1996) Summary page 1.

## Most influential descendants
- K011190: Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System) (2002), 3 descendants of its own
- K020126: Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx TV System) (2002), 2 descendants of its own
- K020952: Surx RF System (2002), 1 descendant of its own
- K042132: Novasys Transurethral RF System (2004), 0 descendants of its own
- K983206: Small Vaginal/Rectal Electrode (1998), 0 descendants of its own

## Indications for use
The Innova® ComfortPulse® Vaginal Electrodes are a component of the Innova Pelvic Floor Stimulation (PFS) System which is indicated for use in the treatment of urinary incontinence. These electrodes are also a component of the Innova® Clinical EMG System which is indicated for monitoring and evaluating EMG activity of the pelvic floor muscles.

Source page: https://510kreport.com/device/K964577
Methodology: https://510kreport.com/methodology