# K970307: Minnova Pelvic Floor Stimulation System

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Apr 22, 1997 after 85 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: 2 generations back to K891773 (1989). 4 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941911: Innova Pelvic Floor Stimulation System, Empi (1995). Our OCR of the scanned summary read K941191, FDA’s number for Real Time Stereotix (GE Medical Systems). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Empi, Inc. Innova Pelvic Floor Stimulation System”.
- K891773: Microgyn II Elec Stim Device Treat of Urin Inconti, Hollister, Inc. (1989) Summary page 1.
- K960496: Liberty Lite PFS System, Utah Medical Products, Inc. (1996) Summary page 1.

## Most influential descendants
- K973096: Neotonus Model 1000 Muscle Stimulator System (1998), 9 descendants of its own
- K162010: HPM-6000U (2016), 7 descendants of its own
- K181497: HPM-6000UF (2018), 6 descendants of its own
- K262353: BTL-299-F (2026), 0 descendants of its own
- K252334: PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) (2026), 0 descendants of its own

## Indications for use
The Minnova Pelvic Floor Stimulation System is indicated for acute and ongoing treatment of urinary incontinence in cases where the following results may improve urinary control: Improvement of urethral sphincter closure, Strengthening of pelvic floor muscles, Inhibition of the detruser muscle through reflective mechanisms.

Source page: https://510kreport.com/device/K970307
Methodology: https://510kreport.com/methodology