# K970602: Vaginal 2 Electrode Stimulation/Emg Probe-Small

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Apr 15, 1997 after 56 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: 1 generation back to K891773 (1989). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891773: Microgyn II Elec Stim Device Treat of Urin Inconti, Hollister, Inc. (1989) Summary page 1.

## Most influential descendants
- K971541: Vaginal 2 Electrode Stimulation/Emg Probe - Tampon (1997), 6 descendants of its own
- K122194: Life-Care Vaginal Probe Life-Care Anal Probe (2013), 3 descendants of its own
- K222528: Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode (2022), 1 descendant of its own
- K161055: Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 (2016), 1 descendant of its own
- K231166: Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes (2024), 0 descendants of its own

## Indications for use
Electrical stimulation of the pelvic floor muscles for the treatment of urinary incontinence. EMG sensing of the pelvic floor muscles

Source page: https://510kreport.com/device/K970602
Methodology: https://510kreport.com/methodology