www.fdanews.com/articles/206946-myndtec-gains-510k-clearance-for-its-myndmove-neuromodulation-device
MyndTec Gains 510(k) Clearance for Its MyndMove Neuromodulation Device
March 14, 2022
Ontario, Canada-based MyndTec has received 510(k) clearance from the FDA for its MyndMove 2.0 neuromodulation device.
The MyndMove system is a touchscreen, eight-channel neuromodulation device that delivers short electrical pulses to stimulate muscle contractions and enhance motor recovery following stroke or spinal cord injury.
The device includes a stimulator unit, electrodes, hand and foot switches and an optional cart for moving it around. The software allows users to choose from several pre-programmed stimulation protocols and to document the treatments.