Re:Balans

The Re:Balans is a non-invasive wearable adhesive patch with four integrated electrodes applied to the patient's back to measure thoracic bioimpedance for fluid management assessment. It is intended for use under physician direction to monitor adult patients with fluid overload (such as end-stage renal disease) and those at risk of dehydration, providing data to assist in fluid management decisions over up to 7 days of continuous wear.

The Re:Balans measures impedance at 45 microamperes at multiple frequencies (including 104 kHz) to calculate base impedance, extracellular resistance, and total resistance, compared to the predicate's single 2 mA measurement at 100 kHz. It uses wireless Bluetooth data transfer to an iOS iPad app rather than cable connection to an acquisition module display, and employs a 3V coin cell battery instead of AA alkaline batteries. It has enhanced ingress protection (IP54 vs. IP20) and is designed for up to 7 days wear versus the predicate's 24-hour testing.

IEC 60601-1-11:2015, IEC 60601-1-2:2014, IEC 60601-1-6:2010, IEC 62304:2006, IEC 81001-5-1:2021, ISO 14155:2020, ISO 10993 series (1, 5, 10, 23), IEC 62366-1, ASTM D4169-22, AAMI TIR57:2016, and AAMI TIR69:2017 for electrical safety, EMC, biocompatibility, software lifecycle, wireless coexistence, usability, and shipping.

Both the Re:Balans and predicate IMED-Z are bioimpedance measurement devices with the same intended use, indications, body placement, prescription-only designation, and suitability for home and clinical settings, sharing the same 4-point tetrapolar electrode geometry. Although the Re:Balans uses lower applied current at multiple frequencies rather than a single frequency, and includes wireless transmission and extended wear time, these differences do not raise new safety or effectiveness concerns as demonstrated by biocompatibility testing, bench performance testing, and clinical data showing the device reliably monitors fluid status changes.