510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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IMKClass II

Wheelchair, Stair Climbing

21 CFR 890.3890 / Physical Medicine
FDA source (opens on fda.gov)

IMK is the FDA product code for Wheelchair, Stair Climbing, a class II device type, regulated under 21 CFR 890.3890. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
IMK
Device name
Wheelchair, Stair Climbing
FDA 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.
Regulation
21 CFR 890.3890
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
4

Clearances, product code IMK

By decision year
3 clearances under product code IMK with a decision year between 2018 and 2025, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IMK by decision year
YearClearances
20181
20211
20251

Applicants with the most clearances

Product code IMK
Applicants holding the most 510(k) clearances under product code IMK
ApplicantClearances
Mobius Mobility LLC2
Deka Research & Development Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code