DeviceClearance

Product code IMK— Physical Medicine

Next Generation iBOT

Classification name
Wheelchair, Stair Climbing
Device class
Class 2
Regulation
21 CFR 890.3890
Advisory panel
Physical Medicine
Total cleared
3
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code IMK under 21 CFR 890.3890, via openFDA

Market context for product code IMK

FDA has cleared 3 devices under product code IMK between 2018 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code IMK

Recent clearances under product code IMK

Data sourced from openFDA. This site is unofficial and independent of the FDA.