Sky Gets 510(k) Clearance for Its Geko Device for Venous Insufficiency and Ischemia
Sky Medical Technology has received 510(k) clearance from the FDA for its geko device for increasing microcirculatory blood flow in lower limb soft tissue.
The geko device is an electrical neuromuscular stimulator. Three recent studies showed that it generates microcirculatory blood flow increase in the lower limbs of patients with venous insufficiency and ischemia.
The UK-based company previously received FDA clearances for edema reduction and for stimulation of the calf muscles to prevent blood clots in both surgical and nonsurgical patients.