Cionic’s Neural Sleeve Gains 510(k) Clearance
San Francisco, Calif.-based Cionic’s leg-worn Cionic Neural Sleeve has received 510(k) marketing clearance from the FDA.
The device delivers functional electrical stimulation to improve the walking ability of people with leg muscle weakness due to multiple sclerosis, stroke, cerebral palsy and other conditions.
The company plans to launch the product on the U.S. market later this year.
Cionic was founded in 2018 by technology innovator, Jeremiah Robison, following his daughter’s cerebral palsy diagnosis.