# K122194: Life-Care Vaginal Probe Life-Care Anal Probe

- Pathway: 510(k) (Traditional)
- Applicant: Everyway Medical Instruments Co.,Ltd
- Decided: Apr 4, 2013 after 254 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). 5 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K971541: Vaginal 2 Electrode Stimulation/Emg Probe - Tampon, Hollister, Inc. (1997) Summary page 3.
- K990456: Anal 2 Electrode Stimulation/Emg Probe - W/Stop, Hollister, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K231166: Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes (2024), 0 descendants of its own
- K140265: Electrode for Urinary Incontinence (2015), 0 descendants of its own

## Indications for use
The Everyway Incontinence Stimulation Electrode, model PR-02/02A, PR-03/03A, PR-04/04A, PR-i OA, PR-il A, PR-i14A for Life-Care VMginal Probe & PR-OSIOBA, PR-i 2A, PR-i 3/1 3A for Life-Care Anal Probe are 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/K122194
Methodology: https://510kreport.com/methodology