FDA Product Code KOI: Stimulator, Nerve, Peripheral, Electric
Leading manufacturers include MIPM Mammendorfer Institut f?r Physik und Medizin GmbH, Senzime AB and Nihon Kohden Corporation.
FDA 510(k) Cleared Stimulator, Nerve, Peripheral, Electric Devices (Product Code KOI)
About Product Code KOI - Regulatory Context
510(k) Submission Activity
28 total 510(k) submissions under product code KOI since 1984, with 28 receiving FDA clearance (average review time: 210 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for KOI submissions have been consistent, averaging 184 days recently vs 213 days historically.
KOI devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →