# K993411: Femiscan Clinic System, Model FS-Ictra and Femiscan Personal System, Model FS-HMTR

- Pathway: 510(k) (Traditional)
- Applicant: Mega Electronics, Ltd.
- Decided: Jan 10, 2000 after 90 days
- Product code: HIR (Perineometer)
- Device class: 2
- Regulation: 21 CFR 884.1425
- 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 K930530 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974048: Incare Pelvic Floor Therapy System with Desktop Computer, Hollister, Inc. (1997) Summary page 1.
- K961872: Incare Pelvic Floor Therapy System with Desktop Computer, Hollister, Inc. (1996) Summary page 1.
- K930530: Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri Inc, Hollister, Inc. (1995) Summary page 1.
- K960311: Perineometer, Hollister, Inc. (1996) Summary page 1.
- K891774: Contimed II Biofeedback Dev Treat of Urin Inconti, Hollister, Inc. (1989) Summary page 1.

## Indications for use
Indications: The FemiScan™ devices are intended as an aid for exercising and training pelvic floor muscle activation, control and optionally coordination with the abdominal muscle group. It is indicated in the treatment of stress and mixed female urinary incontinence under the supervision of a physician. The FemiScan™ Clinic System is used in the physician office, clinic, or hospital environment. The FemiScan™ Personal System is used to supplement these exercises in the home environment.

Source page: https://510kreport.com/device/K993411
Methodology: https://510kreport.com/methodology