# K983206: Small Vaginal/Rectal Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Nov 3, 1998 after 50 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952688: Innova Rectal or Small Vaginal Emg Sensing Electrode, Empi (1995) Summary page 1.
- K954272: Innova Rectal Stimulaton Electrode, Empi (1996) Summary page 1.
- K964577: Innova Comfortpulse Vaginal Electrode (199204)/Innova Comfortpulse Small Vaginal Electrode (199205), Empi (1997) Summary page 1.
- K940091: Innova Vaginal Emg Sensing Electrode, Empi (1994) Summary page 1.

## Indications for use
The electrode is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and monitors and allows assessment of EMG activity of the pelvic floor muscles. The electrode can be used either vaginally and rectally; it should not be interchanged between the two positions. The electrode is reusable between patients if reuse instructions are followed.

Source page: https://510kreport.com/device/K983206
Methodology: https://510kreport.com/methodology