# K243079: NeuroTrac® MyoPlus Pro (MYO120U)

- Pathway: 510(k) (Traditional)
- Applicant: Verity Medical, Ltd.
- Decided: Jun 26, 2025 after 269 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). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083704: Nutrac Pelvator, Model Pel 200, Verity Scientific, Ltd. (2009) Summary page 5.
- K201290: Medline DeNovo 4Pro Electrical Stimulation Device, Medline Industries, Inc. (2020) Summary page 5.

## Indications for use
STIM Electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in adult women. EMG Relaxation muscle training and muscle re-education. ETS Treatment of stress, urge or mixed urinary incontinence by assessing EMG activity of the pelvic floor and strengthening pelvic floor muscles using electrical stimulation. This device is intended to be used by adult woman (aged above 22 years).

Source page: https://510kreport.com/device/K243079
Methodology: https://510kreport.com/methodology