# K972054: Innova Rectal Reusable Electrode/Comfortpulse Regular or Small Reusable Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Aug 14, 1997 after 73 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: 3 generations back to K891773 (1989). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970307: Minnova Pelvic Floor Stimulation System, Empi (1997) Summary page 1.
- K964577: Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small Vaginal Electrode (199205), Empi (1997) 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.

## Indications for use
The electrode is indicated for use in the treatment of urinary incontinence. The electrode is reusable if reuse instructions are followed. The electrode monitors and allows assessment of the EMG activity of the pelvic floor muscles. The electrode is reusable if reuse instructions are followed.

Source page: https://510kreport.com/device/K972054
Methodology: https://510kreport.com/methodology