# K134020: Intonemv

- Pathway: 510(k) (Traditional)
- Applicant: Incontrol Medical, LLC
- Decided: Feb 25, 2014 after 57 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: 8 generations back to K930530 (1995). 25 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110179: Incontrol, Incontrol Medical, LLC (2012) Summary page 1.
- K050483: Evadri Bladder Control Systems, Hollister, Inc. (2005) Summary page 1.

## Most influential descendants
- K181497: HPM-6000UF (2018), 6 descendants of its own
- K182022: ApexMV (2019), 1 descendant of its own
- K262353: BTL-299-F (2026), 0 descendants of its own
- K252601: Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) (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
InToneMV is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of male and female urinary and fecal incontinence.

Source page: https://510kreport.com/device/K134020
Methodology: https://510kreport.com/methodology