Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)

The Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) is an over-the-counter, non-implantable home-use electrical stimulator intended to provide electrical stimulation for rehabilitation of weak pelvic floor muscles to treat stress and urge urinary incontinence in women. The device contains a reusable vaginal electrode, a main stimulator unit powered by an internal rechargeable lithium battery, and offers four treatment modes (P1–P4) with fixed-duration sessions that automatically shut down.

The subject device uses biphasic symmetrical rectangular waveform pulses at 10/30/35 Hz frequency with 100/120 microsecond pulse width, generating 45–52V output at various impedances with maximum 90 mA current at 500Ω. It differs from the predicate (Yarlap) in specific electrical parameters, form factor across three models with varying button counts and dimensions, rechargeable lithium battery versus alkaline battery, and a 25-minute treatment duration versus the predicate's 15–20 minutes. The probe dimensions and electrode surface area also vary slightly between devices.

ISO 10993-1:2018 (biocompatibility), IEC 60601-1:2005+A1:2012+A2:2020 (electrical safety), IEC 62133-2:2017 (battery safety), IEC 60601-1-2:2014+AMD1:2020 (electromagnetic compatibility), IEC 60601-2-10:2012 (nerve and muscle stimulator performance), and FDA guidance on device software content. UN 38.3 testing for lithium batteries was also performed.

The subject device is substantially equivalent to the predicate Yarlap device because both share the same intended use (electrical stimulation for pelvic floor muscle rehabilitation treating stress and urge incontinence), similar technological characteristics (biphasic symmetrical stimulation via vaginal electrode), and the same mechanism of action (muscle contraction through electrical stimulation). Differences in electrical parameters, form factor, battery type, and treatment duration do not raise different questions of safety or effectiveness, and non-clinical testing demonstrates the subject device performs as safely and effectively as the predicate.