Regenesis EMS Chair

The ReGenesis EMS Chair is an electromagnetic muscle stimulation device that provides non-invasive stimulation to weak pelvic floor muscles for rehabilitation and treatment of urinary incontinence in male and female patients. It consists of a chair-based applicator with an internal electromagnetic coil and a wired control panel with touch screen interface, intended for use by trained professionals in hospital and clinic settings.

The subject device uses a rectangular biphasic pulse shape with 310 μs pulse width at 1-50 Hz repetition rate and up to 24 mT/μs pulse intensity variation, powered by AC110-120V at 12A. The predicate uses sine biphasic pulses at 280 μs with 1-150 Hz rate and up to 28 mT/μs intensity. Both use magnetic coils in chair applicators, have firmware-controlled touch screen interfaces, support 0-100% amplitude adjustment, and are limited to hospital/clinic environments. The subject device supports shorter therapy sessions (0-30 min vs. 0-60 min) and has slightly smaller applicator dimensions (27x24x27 in. vs. 29x29x29 in.).

IEC 60601-1:2020 (electrical safety for medical equipment), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 60601-2-10:2016 (nerve and muscle stimulator requirements), and FDA guidance for software verification and validation in medical devices. Performance testing included service life verification and stimulation coil surface temperature rise testing.

Although the subject and predicate devices have different technological characteristics (rectangular vs. sine biphasic pulses, 310 μs vs. 280 μs pulse width, 1-50 Hz vs. 1-150 Hz rate, smaller applicator dimensions), these differences do not raise different questions of safety or effectiveness because both devices share the same intended use—non-invasive electromagnetic stimulation for pelvic floor muscle rehabilitation to treat urinary incontinence—use the same energy type (magnetic field), employ the same applicator concept (chair-based), and are operated identically in clinical settings by trained professionals. Performance testing validated that the subject device meets all predetermined acceptance criteria for safety, electromagnetic compatibility, and device durability.