XOD Diathermia Radiofrequency Device

The XOD Diathermia Radiofrequency Device is a portable therapeutic device that generates high-frequency radiofrequency energy to elevate tissue temperature for treating pain, muscle spasms, and improving local circulation. It also provides temporary reduction in the appearance of cellulite through topical heating delivered via monopolar electrodes.

The device operates at 442–454 kHz frequency with a maximum RF power of 350W and supports input voltage of 100–240V at 50/60 Hz. It features resistive threaded electrodes and a silicon return plate in a portable console with color touchscreen, offering adjustable treatment intensity (0–100%) and 20–30 minute treatment sessions targeting tissue temperatures of 40–45°C.

The device was tested to IEC 60601-1 and IEC 60601-1-6 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility (EMC), and ISO 10993-1 for biocompatibility assessment of patient-contacting components.

The XOD device is substantially equivalent to the predicate Indiba device because both share identical indications for use, the same principle of operation (monopolar radiofrequency heating), overlapping frequency ranges (442–454 kHz vs. 400–449 kHz), identical maximum tissue temperature targets (40–45°C), and use resistive electrodes. Both meet the same electrical safety and EMC standards; differences in portable form factor, power output (350W vs. 200W), and treatment duration do not affect the fundamental intended use or safety profile.