FDA Product Code IMK: Wheelchair, Stair Climbing
A Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. The Device Is Intended To Climb Stairs. Fda Interprets mobility To Persons Restricted To A Sitting Position To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And Require An Assistive Device For Mobility.
Leading manufacturers include Mobius Mobility.
FDA 510(k) Cleared Wheelchair, Stair Climbing Devices (Product Code IMK)
About Product Code IMK - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code IMK since 2018, with 3 receiving FDA clearance (average review time: 116 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under IMK have taken an average of 85 days to reach a decision - down from 132 days historically, suggesting improved FDA processing for this classification.
IMK devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →