FDA product code · Physical medicine

Wheelchair, Stair Climbing

Name: FDA decisions, review times, recalls and adverse event reports for product code IMK
Creator: 510(k) Report

IMKClass II21 CFR 890.3890510(k) required5 decisions since 19913 recalls

5 FDA decisions since 1991. 510(k) reviews decided 2021–2025 took a median of 82 days (half between 81 and 84). 3 recalls name this code, 0 of them Class I. The most-cited predicate is P020033/S002, named by 1 later device.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, physical medicine panel

Twenty years of IMK at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · IMK

1in 2025

2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IMK

Too few IMK 510(k)s in any year since 2007 to give a median.

Recalls per year · IMK

1in 2010

2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IMK

10in 2025

2007high 12 (2008) · low 0 (2015)2025

MAUDE reports naming product code IMK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	8
2008	0	—	0	12
2009	0	—	0	11
2010	0	—	1	5
2011	0	—	0	5
2012	0	—	0	4
2013	0	—	0	1
2014	0	—	0	1
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	1	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	1	—	0	4
2022	0	—	0	3
2023	0	—	0	2
2024	0	—	0	2
2025	1	—	0	10
2026	0	—	0	—

FIG. 1 — IMK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in IMK? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Wheelchair, Stair Climbing

Which predicates do IMK devices cite most?

Which IMK devices have the deepest lineage?

What has FDA decided in IMK lately?

What has been recalled in IMK lately?