FISIOWARM 7.0

FISIOWARM 7.0 (300 and 400 models) are radiofrequency-based therapeutic devices that provide topical heating to elevate tissue temperature for treating pain, muscle spasms, and improving local circulation. The devices also provide temporary reduction in the appearance of cellulite through massage functionality.

Both models operate at 300 kHz–1 MHz radiofrequency with 100–240 VAC power supply. The 7.0 300 outputs 300W while the 7.0 400 outputs up to 400W (30% more power for intensive use). Both support unipolar, bipolar, and multifunction outputs with identical handpiece types (resistive and capacitive) and electrode options (resistive, capacitive, neutral, dermato-functional, static automatic, neutral dynamic) as the predicate Winback Back 3SE.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-2-2, and ISO 10993-1 (biocompatibility of handpieces and electrodes). Comparative thermal testing on human skin verified energy transfer equivalence at different energy levels.

The FISIOWARM 7.0 devices have identical intended use, operating principle (radiofrequency heating), frequency range, and electrode/handpiece specifications as the predicate Winback Back 3SE. Both comply with the same electrical safety standards and both employ resistive/capacitive technologies. Performance testing demonstrated equivalent thermal tissue energy transfer characteristics. The only material difference is increased power capacity (400W vs 300W), which supports rather than contradicts equivalence for the same therapeutic application.