PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)

The PELVIPOWER PelvicFMS is a non-invasive pelvic floor muscle stimulator that uses electromagnetic field impulses to strengthen and rehabilitate weak pelvic muscles and restore neuromuscular control. It is intended for treatment of male and female urinary incontinence and is delivered via an adjustable chair with a 12-inch touchscreen interface in healthcare facilities.

The subject device generates magnetic field intensity of 0.5–2 T at pulse repetition rates of 5–50 Hz with 340 µs pulse width, adjustable in 6 increments, with therapy sessions up to 22 minutes. The predicate generates 0.7–2.5 T at 1–150 Hz with 280 µs pulse width, adjustable 0–100%, with up to 30-minute sessions. The subject device includes a novel 150 mm horizontal coil adjustment feature absent in the predicate, and a smaller seat applicator (51×54 cm vs. 73×73 cm).

Testing per IEC 60601-1:2020 (electrical safety), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 60601-4-2:2024 (EMC test guidance), FDA guidance on software verification/validation and cybersecurity, and ASTM F2182-19E02 for coil temperature rise.

Both devices have the same intended use, function, energy type, stimulation source, and prescription-only status. Although the subject device has different technological characteristics (magnetic field intensity range, pulse parameters, therapy time, and novel coil adjustment), performance testing demonstrated these differences do not raise different questions of safety or effectiveness. The BTL-398 was used as reference for coil movement testing, and all acceptance criteria were met.