HEBE (NP0000763)

HEBE is a radiofrequency (RF) device operating at 448 kHz intended to provide topical heating to elevate tissue temperature for pain relief, muscle spasm reduction, and increased local circulation. It features three RF application modes: monopolar capacitive, monopolar resistive, and bipolar resistive electrodes, all delivering therapeutic heat to musculoskeletal conditions.

HEBE uses 448 kHz radiofrequency with maximum output of 200 W and treatment temperature range of 43–45 °C. It includes monopolar capacitive electrodes (20, 40, 60, 80 mm diameters), monopolar resistive electrodes (40, 60, 80 mm), and bipolar resistive electrodes (30, 70 mm), all with specified power densities. The device incorporates current-controlled temperature regulation, internal over-temperature protection via fan, and external IR thermometry for monitoring, plus reusable return plates (stainless steel) and conductive cream application.

IEC 60601-1 (general safety), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-1-6 (usability), IEC 60601-2-2 (high-frequency surgical equipment), IEC 62304 (software life cycle). Biocompatibility per ISO 10993-1-2018, ISO 10993-5-2009 (cytotoxicity), and ISO 10993-10-2010 (irritation and sensitization).

HEBE is substantially equivalent because it shares the same product code (PBX—massager/vacuum/RF-induced heat), regulation (21 CFR 878.4400), indications for use (pain relief, muscle spasm, circulation), and principle of operation (RF heating) as predicate devices NuEra Tight RF Family (K210867) and Deep Care (K161458). Performance testing confirms similar temperature control mechanisms, safety features (over-temperature protection, contact detection), and biocompatibility. Although HEBE adds a bipolar resistive electrode option and specifies different electrode sizes and power densities, these variations remain within the technological scope already cleared for the predicate, and non-clinical testing demonstrates equivalent safety and efficacy.