FDA Product Code GZI: Stimulator, Neuromuscular, External Functional
Leading manufacturers include Neuvotion, Inc., Synapse Biomedical, Inc. and Cionic, Inc..
FDA 510(k) Cleared Stimulator, Neuromuscular, External Functional Devices (Product Code GZI)
About Product Code GZI - Regulatory Context
510(k) Submission Activity
61 total 510(k) submissions under product code GZI since 1977, with 61 receiving FDA clearance (average review time: 153 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under GZI have taken an average of 237 days to reach a decision - up from 147 days historically. Manufacturers should account for longer review timelines in current project planning.
GZI devices are reviewed by the Neurology panel. Browse all Neurology devices →