Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)

The Indiba Diathermia Radiofrequency Activ (Activ CT9) and Deep Care (EVONY) devices are non-invasive therapeutic consoles that generate radiofrequency current delivered through two electrode types to provide topical heating for relieving pain, muscle spasms, and improving local circulation. The Activ CT9 also includes massage applicators to temporarily reduce the appearance of cellulite.

Both devices operate at 448 kHz monopolar RF frequency with 200 W maximum output in resistive (RES) mode and 450 VA in capacitive (CAP) mode. Key improvements include larger touchscreen displays (21.5" for EVONY, 8" for Activ CT9 vs. 5.7" predicate), smart handles with automatic applicator identification (EVONY only), refined graphical user interfaces, new electrode designs (Sculpture for EVONY; Fascia and Target for Activ CT9), and temperature tracking capability (EVONY). All core RF specifications and output parameters remain identical to predicates.

ANSI AAMI ES60601-1:2005/(R)2012 with amendments (general electrical safety); IEC 60601-1-2 Edition 4.1 2020-09 (electromagnetic compatibility); IEC 60601-2-2 Edition 6.0 2017-03 (high-frequency surgical equipment). Testing included software verification and validation, electrical safety and EMC testing, RF power control and accuracy testing, and labeling verification.

Both subject devices employ identical underlying monopolar RF technology, frequency (448 kHz), and maximum power outputs as their predicates (Activ 902 and ELITE, respectively). New electrodes (Sculpture, Fascia, Target) operate identically to already-cleared RES and CAP electrodes with no new mechanism of action. Improvements are primarily to user interface, display size, and convenience features (smart handles, temperature tracking) that do not introduce new safety or effectiveness risks. All materials contacting skin are biocompatible and identical to predicates. Performance testing was conducted using identical protocols to predicates and confirmed equivalence in all electrical, mechanical, and thermal safety parameters.