Levina Pelvic Floor Muscle Stimulator (RS-48)

The Levina Pelvic Floor Muscle Stimulator (RS-48) is a non-implantable home-use device that delivers electrical stimulation via an intravaginal probe to strengthen pelvic floor muscles. It is intended to treat stress, urge, and mixed urinary incontinence in women and to maintain urinary continence through neuromuscular reeducation and Kegel-like muscle contractions.

The subject device uses biphasic, symmetrical rectangular waveforms with pulse widths of 200–300 microseconds and frequencies of 12–50 Hz. Compared to the predicate Yarlap II, the subject device has narrower frequency range (12–50 Hz vs. 2–100 Hz), lower maximum output voltage at 10 kΩ (50 V vs. 95 V), and lower maximum output current across impedance levels. The electrode area and current density profiles are similar, with the subject device measuring 6 cm² versus the predicate's 6.4 cm².

Testing was performed per ISO 10993-1:2018 (biocompatibility), IEC 60601-1:2020 (electrical safety), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 60601-1-11 (home healthcare environment requirements), IEC 60601-2-10 (nerve and muscle stimulator requirements), FDA guidance on software verification and validation, and FDA cybersecurity guidance (September 27, 2023).

Both devices share identical indications for use, target population, environment of use, prescription/OTC status, electrode type (incontinence probe), and waveform characteristics (biphasic, symmetrical). Although the subject device has lower maximum output parameters at certain impedance levels and a narrower frequency range, the submission demonstrates through reference devices and performance testing that these differences do not raise different questions of safety or effectiveness. The subject device's parameters are supported by predicate and reference device data, and all electrical performance and biocompatibility testing met acceptance criteria.