Zionic Pro Max (EMS)

The Zionic Pro Max is an electrical muscle stimulation (EMS) device that generates electrical impulses to stimulate healthy muscles and improve muscle performance. It consists of a console with user interface and multiple handpieces that deliver EMS energy through intact skin, intended for use by medical professionals for muscle stimulation rather than rehabilitation or physiotherapy.

The device is AC line-powered (120V, 60Hz) unlike the battery-powered predicate, uses a symmetrical bi-phasic square waveform at 3-40 Hz frequency, delivers 96 mA maximum current at 500Ω, has 4 isolated channels with regulated current output, and is a floor-standing unit rather than handheld. It provides only NMES waveforms without TENS capability.

IEC 60601-1 Edition 3.2 (general medical electrical equipment safety), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-2-10 (nerve and muscle stimulator requirements), IEC 62304 (software life cycle), EN ISO 14971 (risk management), and ISO 10993-1 (biocompatibility including cytotoxicity, sensitization, and irritation testing).

The device shares the same indications for use and general design as the predicate (Compex Sport Elite 3.0 K201653), with substantially equivalent waveform characteristics, channel configuration, and safety features. Technological differences in power source, form factor, frequency range, and output parameters do not impact safety or effectiveness, as they fall within acceptable ranges of other cleared Class II muscle stimulator devices.