# K963222: Microgyn Plus Stimulation Device

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Oct 23, 1996 after 68 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). 3 ancestors in all.
26 later devices descend from it; 3 cite it directly.
0 of 30 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.
- K910081: TBD, Empi (1991) Summary page 1.

## Most influential descendants
- K023905: Athena Pelvic Muscle Trainer (2003), 14 descendants of its own
- K033256: Athena Pelvic Muscle Trainer II (2003), 13 descendants of its own
- K081480: KEGEL8 Pelvic Exerciser, Model Oph 400 (2008), 12 descendants of its own
- K141643: Yarlap (2015), 10 descendants of its own
- K973096: Neotonus Model 1000 Muscle Stimulator System (1998), 9 descendants of its own

## Indications for use
The Microgyn Plus Stimulation Device is intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence in women.

Source page: https://510kreport.com/device/K963222
Methodology: https://510kreport.com/methodology