FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Sky Medical Receives 510(k) Clearance for Edema Reduction

March 8, 2018
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Sky Medical Technology received 510(k) clearance to market its geko device for edema reduction in clinical applications.

The disposable battery powered device is the size of a wristwatch and delivers neuromuscular electrostimulation, increasing blood flow equal to 60% of walking without the user having to move or exert energy.

U.K.-based Sky Medical Sky is the developer of the OnPulse neuromuscular electrostimulation platform.

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