# K971527: Innosense Pelvic Floor Stimulation and Electromyography System

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Jun 30, 1997 after 63 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892649: Verimed Myoexorciser Iii (Myo Iii), Verimed Holdings, Inc. (1989) Summary page 1.
- K935213: Incontrol, Thought Technology, Ltd. (1995) Summary page 1.
- K893220: Verimed Myoexorciser Veristim, Verimed Holdings, Inc. (1990) Summary page 1.
- K941911: Innova Pelvic Floor Stimulation System, Empi (1995) Summary page 1.
- K970307: Minnova Pelvic Floor Stimulation System, Empi (1997) Summary page 1.

## Indications for use
The InnoSense System is indicated for acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Improvement of urethral sphincter closure, Strengthening of pelvic floor muscles, Inhibition of the detruser muscle through reflexive mechanisms. It is also indicated during incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles.

Source page: https://510kreport.com/device/K971527
Methodology: https://510kreport.com/methodology