Well-Life Incontinence Stimulation System (WL-2405i(P))

The Well-Life Incontinence Stimulation System (WL-2405i(P)) is a non-implantable home-use pelvic floor muscle stimulator that delivers electrical stimulation to treat stress, urge, and mixed urinary incontinence in adult women. It contains a rechargeable lithium-ion battery-powered stimulator unit, a vaginal probe electrode, and offers four treatment modes with adjustable intensity levels.

Both subject and predicate devices use pelvic floor electrical stimulation via vaginal probe with four output modes and one output channel. Key differences include: subject device uses 3.7V Li-ion battery versus predicate's AA batteries; subject outputs 40V/80mA at 500 ohms versus predicate's 45V/90mA; subject allows timer adjustment from 5-20 minutes versus predicate's 0-90 minutes. Electrical stimulation parameters (pulse width, frequency, waveform) are identical.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-11 (home healthcare environment), IEC 60601-2-10 (nerve and muscle stimulators), ISO 10993-1 (biocompatibility), and FDA guidance for software verification and validation.

The subject and predicate devices share the same indications for use, intended population, OTC designation, and fundamental electrical stimulation technology. Minor design differences (battery type, slight voltage/current variations, timer range) do not affect principles of operation or safety. Performance testing confirms the subject device is as safe and effective as the predicate, and differences do not raise distinct safety or effectiveness questions.