(107 days)
The NESS L300 Foot Drop System is intended to provide ankle dorsiflexion in individuals (adults and pediatrics) who have foot drop following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot. The NESS L300 may improve gait, facilitate muscle re-education, prevent or retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow.
The L300 Foot Drop System consists of Control Unit and Intelli-Sense Gait Sensor.
I'm sorry, but this document does not contain the information requested regarding acceptance criteria and studies proving the device meets those criteria. The provided text is a 510(k) Summary and an FDA clearance letter for the Bioness L300 Foot Drop System, focusing on its substantial equivalence to predicate devices and expanded indications for use. It outlines the device description, indications for use, and regulatory information, but does not detail specific performance acceptance criteria or the results of a study designed to demonstrate them.
§ 882.5810 External functional neuromuscular stimulator.
(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).