# K161055: Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15

- Pathway: 510(k) (Traditional)
- Applicant: Fuji Dynamics, Ltd.
- Decided: Jul 12, 2016 after 89 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.
1 later device descends from it; 1 cites it directly.
0 of 7 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 4.
- K990456: Anal 2 Electrode Stimulation/Emg Probe - W/Stop, Hollister, Inc. (1999) Summary page 4.

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

## Indications for use
The Fuji Dynamics Incontinence Stimulation Electrodes are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Source page: https://510kreport.com/device/K161055
Methodology: https://510kreport.com/methodology