Pelvic Floor Exerciser (PF01)

The Pelvic Floor Exerciser (PF01) is a vaginal probe with sensors that measures pelvic floor muscle contraction strength during Kegel exercises. It transmits wireless data to a smartphone app providing real-time visual biofeedback through gamified exercises. It is intended to treat stress, mild-moderate urge, and mixed urinary incontinence in adult women by strengthening pelvic floor muscles.

The subject device uses force sensing resistors (wireless) housed in a rigid PC/ABS plastic structure covered with medical-grade silicone. It has two egg-shaped sensing areas, a shaft length of 88.5 mm, weighs 42g, and is powered by non-rechargeable 3.0VDC batteries. It operates as a single-patient reusable device with smartphone GUI interface, measuring uncalibrated force output from the pubococcygeus and puborectalis muscles. These characteristics are substantially similar to the predicate Perifit Care+ (K231780).

Biocompatibility testing per ISO 10993-1; Electrical safety per IEC 60601-1:2020 and IEC 60601-1-11:2020; Electromagnetic compatibility per IEC 60601-1-2:2020 and IEC 60601-4-2:2024; Software verification and validation per FDA guidance; Cybersecurity verification per FDA guidance. Performance testing included tensile strength, bending, cleaning validation, sensor accuracy, Bluetooth connectivity, dimensional verification, vibration/drop, and battery life testing.

The subject device is substantially equivalent to the predicate Perifit Care+ because both devices have identical indications for use (treating urinary incontinence via pelvic floor muscle strengthening), the same principle of operation (vaginal probe with wireless force sensing and smartphone feedback), equivalent technological characteristics (same materials, sensor type, power source, and user interface), and both are single-patient reusable over-the-counter devices. Performance testing confirmed safety and effectiveness across all predefined acceptance criteria.