# K053434: Myotrac Infiniti Electrical Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Thought Technology, Ltd.
- Decided: Mar 15, 2006 after 96 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: 5 generations back to K930530 (1995). 10 ancestors in all.
36 later devices descend from it; 4 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023906: Pathway CTS2000 Pelvic Floor Training System, The Prometheus Group (2003) Summary page 7.
- K974048: Incare Pelvic Floor Therapy System with Desktop Computer, Hollister, Inc. (1997) Summary page 7.
- K002154: K.E.A.T., Emd Electronic Medical Devices, Corp. (2001) Summary page 7.
- K050483: Evadri Bladder Control Systems, Hollister, Inc. (2005) Summary page 7.
- K994109: Detrusan 500, Innovamed USA, Inc. (2000) Summary page 7.

## Most influential descendants
- K080950: Stiwell MED4 (2009), 34 descendants of its own
- K110179: Incontrol (2012), 21 descendants of its own
- K134020: Intonemv (2014), 10 descendants of its own
- K141158: APEX (2014), 9 descendants of its own
- K181497: HPM-6000UF (2018), 6 descendants of its own

## Indications for use
The MyoTrac Infiniti system is indicated for acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscle through reflexive mechanisms, strengthening of pelvic floor muscle. 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. The MyoTrac Infiniti system is also indicated for the ongoing treatment of the following conditions: Relaxation of Muscle Spasms, Prevention or retardation of disuse atrophy, increasing local blood circulation, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion and Stroke Rehab by Muscle re-education. It is also used for Biofeedback, Relaxation & Muscle Re-Education purposes.

Source page: https://510kreport.com/device/K053434
Methodology: https://510kreport.com/methodology