myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)

Myosmart is a myoelectric control system for upper limb prosthetics that uses surface electrodes to detect muscle signals and enable personalized, adaptive prosthesis control. It includes a control unit, flexible armband cuff with integrated battery, and mobile app for signal evaluation and calibration without requiring a check socket.

The device uses Bluetooth 5.0 wireless communication, operates at 6–8.2 VDC input voltage, includes pattern recognition with joint change detection, has 2–4 compatible electrodes, and uses digital signal processing at 80–500 Hz bandwidth. It is dimensionally identical to the primary predicate (67 × 27 × 9.2 mm) and weighs 15g, with housing materials of acrylonitrile styrene acrylate or polyamide with titanium contact areas.

ISO 14971:2019 (risk management), IEC 62366-1:2015+A1:2020 (usability), IEC 62304:2006+A1:2015 (software lifecycle), IEC 60601-1:2005+A1:2012+A2:2020 (electrical safety), IEC 60601-1-2:2014+AMD1:2020 (EMC), IEC 62133-2:2017 (battery safety), ISO 10993-1:2018 (biocompatibility), and ISO 20417:2021 / ISO 15223-1:2021 (labeling).

Myosmart has identical intended use (exoprosthetic fittings of upper limbs) and same fundamental design as the primary predicate (Myo Plus K191179). Differences in power input voltage, pattern recognition features, and Bluetooth version do not raise new safety or effectiveness concerns. All nonclinical testing demonstrates acceptable safety and performance, and both compatible electrode types were previously cleared under K123795 and K191179.