# K971541: Vaginal 2 Electrode Stimulation/Emg Probe - Tampon

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Jun 25, 1997 after 58 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). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 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.
- K930530: Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc, Hollister, Inc. (1995) Summary page 1.
- K970602: Vaginal 2 Electrode Stimulation/Emg Probe-Small, Hollister, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K210441: Incontinence Probe (2021), 0 descendants of its own

## Indications for use
The Vaginal Stimulation/EMG Probe - Tampon, is intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Source page: https://510kreport.com/device/K971541
Methodology: https://510kreport.com/methodology