Aura Wave

The Aura Wave is a noninvasive physical medicine device that uses electrically generated magnetic fields to stimulate muscles. It is indicated to temporarily increase local blood circulation in healthy leg muscles and to stimulate healthy muscles to improve or facilitate muscle performance. The system consists of a main control unit with five interchangeable coil attachments of varying sizes for treating different body areas, and is available for both home care and clinical professional use.

The Aura Wave operates at up to 0.19 T magnetic field output with a pulse repetition rate of 0.4 to 5.8 Hz, pulse duration of 0.13 to 0.24 mS, and power consumption of 90 watts maximum. It has a therapy timer of 1–90 minutes (10-minute default), one output channel, and a simple 5-button user interface with operator-controlled power levels 1–20. The device is microprocessor-controlled, weighs 8.1 pounds, and complies with IEC 60601 series safety and EMC standards.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62366-1, IEC 62304, ISO 10993-1, ISO 10993-5, and ISO 10993-10. Performance testing measured signal waveform output and magnetic flux at all intensity levels.

The Aura Wave is substantially equivalent to the BEMER Pro Set (predicate K210174) because both are noninvasive microprocessor-controlled devices using electrically generated magnetic fields to stimulate muscles with identical indications for use, similar accessories for targeted treatment, operator-adjustable timers and power output, and equivalent safety and performance testing. Although the Aura Wave has a longer therapy timer range and higher power consumption, these differences do not raise new safety or effectiveness concerns and the devices remain substantially equivalent in therapeutic range.