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 and Deka Research & Development Corp..
3
Total
3
Cleared
116d
Avg days
2018
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times improving: avg
85d
recently vs 132d historically
FDA 510(k) Cleared Wheelchair, Stair Climbing Devices (Product Code IMK)
3 devices
Cleared
Jan 30, 2025
iBOT® PMD
Mobius Mobility
Physical Medicine
85d
Cleared
Jun 16, 2021
iBOT Personal Mobility Device (iBOT PMD)
Mobius Mobility
Physical Medicine
79d
Cleared
Mar 02, 2018
Next Generation iBOT
Deka Research & Development Corp.
Physical Medicine
184d
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 510(k) Review Time - IMK Product Code
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 →