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Medical Devices / Submissions and Approvals

Bioness Gains FDA Clearance for the L300 Go System

Feb. 8, 2017
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Valencia, California–based, Bioness received marketing clearance from the FDA for the L300 Go System.

The L300 Go provides 3D motion detection of gait, multi-channel stimulation and includes a mobile application to track user activity. The device delivers electrical stimulation and uses data from a 3-axis gyroscope and accelerometer.

Patient movement is monitored in all three planes and stimulation is deployed when needed during the gait cycle.  An adaptive, learning algorithm accommodates changes in gait dynamics and a high speed processor deploys stimulation within 10 milliseconds of detecting a valid gait event. — Cynthia Jessup

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