NeuroTrac® MyoPlus Pro (MYO120U)

The NeuroTrac® MyoPlus Pro (MYO120U) is a single-channel pelvic floor muscle stimulator for treating stress, urge, and mixed urinary incontinence in adult women aged 22+. It operates in three modes: STIM (electrical stimulation and neuromuscular re-education), EMG (relaxation and muscle re-education), and ETS (EMG-triggered stimulation). The device delivers symmetrical, biphasic, rectangular waveforms via a vaginal probe and can be operated by a physician or patient under physician instruction.

The subject device generates constant-current, biphasic stimulation at 2–100 Hz with maximum output of 45V @ 500Ω, 103V @ 2kΩ, and 170V @ 10kΩ. It uses a single output channel for stimulation and two for EMG, powered by 4×AAA alkaline batteries (6V), with program durations of 15–99 minutes. The primary predicate (K083704) shares identical voltage, frequency, and waveform characteristics. The secondary predicate (K201290) has lower maximum voltages (40V/70V) and different power density but comparable functional architecture.

IEC 60601-1:2020 (medical electrical equipment basic safety and essential performance), IEC 60601-1-2:2020 (electromagnetic compatibility), FDA guidance on software verification and validation for medical devices, and FDA cybersecurity guidance (September 27, 2023).

The subject device has identical intended use and same core safety/performance parameters (voltage, frequency, waveform shape, current regulation, net charge) as the primary predicate (K083704) for STIM mode, and substantially overlapping characteristics with the secondary predicate (K201290) for EMG/ETS modes. Although minor technological differences exist in power density and battery source, performance testing confirmed these differences do not raise new safety or effectiveness questions. All electrical safety, EMG, and software validation testing met acceptance criteria, establishing that functional and operational equivalence has been demonstrated.