Active System; Avenue8

The Caerus Active System and Avenue8 are portable, non-invasive devices that deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) therapy combined with thermal exchange or electronic heat. Both are indicated for adjunctive use in temporary relief of pain associated with over-exertion, strains, sprains, and arthritis, and are intended for prescription use only by adult users.

Both devices operate at 27.12 MHz shortwave frequency with 50 Ohm output impedance, 2 Hz burst frequency, and 2 ms burst width. The Active System delivers 1.35 W peak generator power via induction coil with chemical heating for up to 1 hour, while Avenue8 delivers 1.35 W peak power with electrical heating for up to 1 hour—both differing from predicate devices that used 0.5 W power and 30-minute exposures.

IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility (EMC). Non-clinical testing included peak output power, pulse characteristics, specific absorption rates, electrical and magnetic field characterization in saline gel test loads, and temperature maintenance testing.

The devices demonstrate substantial equivalence through identical regulatory classification, indications for use targeting same pain conditions in superficial soft tissue, identical shortwave frequency and burst parameters, and same energy deposition method (induction coil) as predicates. While the devices have higher peak power (1.35 W vs. 0.5 W) and longer exposure (1 hour vs. 30 minutes), these differences were justified by clinical study data showing the Active System achieved 36% pain reduction versus 10% for standard care alone, with no serious adverse events, establishing that the technological differences do not raise different safety and effectiveness questions.