XBody Go USA, XBody Pro USA

The XBody Go USA and XBody Pro USA are electrical muscle stimulation (EMS) devices designed to stimulate healthy muscles to improve or facilitate muscle performance and muscle training. They are portable systems intended for use by trained operators in home healthcare environments and are not for rehabilitation or treatment of medical conditions. The devices use electrical impulses to trigger muscle contractions through motor nerves.

The subject devices are identical to the predicate in output specifications, waveform, frequency range, pulse width, and safety circuits. Key differences include: expanded control unit options (Surface Go 3/4 and Pro 9/10 versus only Go 2 and Pro 7 in predicate), optional XBody DrySuit with 10 channels versus predicate's TS 2.1/3.0 with 12 channels, and new XBody DryWear accessory. All electrical output parameters, burst modes, and battery specifications remain unchanged.

IEC 60601-1:2005+A1:2012+A2:2020 (general medical device safety), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), IEC 60601-1-6:2010+A1:2013+A2:2020 (usability), IEC 60601-1-11:2015+A1:2020 (home healthcare), IEC 60601-2-10:2012+A1:2016 (nerve and muscle stimulators), IEC 62304:2006+A1:2015 (software life cycle), ISO 10993 series (biocompatibility), and EN ISO 14971:2019 (risk management).

The subject devices demonstrate substantial equivalence because they maintain identical intended use, indications, output specifications, safety circuits, and performance characteristics as the predicate K221200. Although new control unit models and the optional DrySuit have been added, these represent evolutionary improvements that do not alter safety or effectiveness—independent electrical and electromagnetic testing confirmed these differences enhance user interface only. The DrySuit performs equivalently to the existing training suits already cleared for the predicate devices, and all applied parts meet the same biocompatibility standards.