EMS (FlexPulse, MagnaCore, Magnetika)

The EMS device (FlexPulse, MagnaCore, MagnetiKa) is an electromagnetic muscle stimulator for non-invasive strengthening and toning of abdominal muscles, buttocks, and thighs. It consists of a main unit with power supply, control unit with touchscreen display, and handpiece tools with electromagnetic induction coils that generate a magnetic field to stimulate muscle contractions.

The device generates a magnetic field of 0.5–1.8 T (±20%) with maximum intensity of 1.0 T (±20%) at the applicator center surface. It operates continuously at 1–150 Hz pulse repetition rate with symmetrical biphasic sine wave pulses of 270 ±20% microseconds, inducing 20.6 mA current in tissue. It features a 15.6-inch touch screen interface, dual outputs for simultaneous treatment, and therapy duration up to 60 minutes.

IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-10:2016, IEC 60601-1-6:2013, ISO 10993-5:2009, and ISO 10993-10:2010. The device complies with medical electrical equipment safety standards and biocompatibility requirements for in vitro cytotoxicity and skin irritation/sensitization testing.

The device achieves substantial equivalence because it has identical intended use, primary function (muscle stimulation via action potential initiation), and operational parameters (magnetic field type, pulse rate, therapy time, application method) as the predicate BTL 799-2. Minor differences—such as 1.0 T versus 1.154 T maximum field intensity and 270 µs versus 280 µs pulse duration—fall within acceptable ranges and do not affect safety or effectiveness. The lower induced current (20.6 mA vs 28–30 mA) actually enhances safety while maintaining clinical effect.