510(k) K213622

Cionic Neural Sleeve NS-100 by Cionic — Product Code GZI

K213622 is an FDA 510(k) premarket notification submitted by Cionic for the device "Cionic Neural Sleeve NS-100". The FDA issued a decision of Substantially Equivalent on February 14, 2022. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810. Cionic has at least 2 other 510(k) clearances on record.