# K201014: MyOnyx System

- Pathway: 510(k) (Traditional)
- Applicant: Thought Technology, Ltd.
- Decided: Jan 13, 2021 after 271 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: 6 generations back to K930530 (1995). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053434: Myotrac Infiniti Electrical Stimulator, Thought Technology, Ltd. (2006) Summary page 4.

## Most influential descendants
- K213043: Levator Elite (Model LE9011) (2022), 0 descendants of its own

## Indications for use
The MyOnyx System is indicated for acute and ongoing treatment of stress, urge, or mixed urinary incontinence, where urinary control may be improved through electrical stimulation that strengthens the pelvic floor muscles or inhibits the detrusor muscle through reflexive mechanisms. The system also uses EMG-based or pressure-based biofeedback to help control and strengthen the pelvic floor muscles in the treatment of urinary incontinence.

Source page: https://510kreport.com/device/K201014
Methodology: https://510kreport.com/methodology