IORClass I

Wheelchair, Mechanical

21 CFR 890.3850 / Physical Medicine

IOR is the FDA product code for Wheelchair, Mechanical, a class I device type, regulated under 21 CFR 890.3850. FDA's definition for this code reads: "A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. 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 2026-09-10, FDA records hold 463 510(k) clearances under this code, the most recent dated 2026-08-06, and 40 recalls.

Classification record

Product code: IOR
Device name: Wheelchair, Mechanical
FDA definition: A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. 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/or require an assistive device for mobility.
Regulation: 21 CFR 890.3850
Device class: Class I
Review panel: Physical Medicine
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 468
Ingested recalls: 40

Clearances, product code IOR

By decision year

468 clearances under product code IOR with a decision year between 1978 and 2026, 1995 the highest year at 36.

Show the numbers

510(k) clearances under FDA product code IOR by decision year
Year	Clearances
1978	1
1979	1
1980	1
1983	3
1984	7
1985	11
1986	10
1987	12
1988	12
1989	5
1990	9
1991	12
1992	9
1993	17
1994	20
1995	36
1996	4
1997	11
1998	18
1999	16
2000	23
2001	12
2002	23
2003	9
2004	13
2005	19
2006	15
2007	5
2008	13
2009	4
2010	12
2011	6
2012	11
2013	7
2014	7
2015	3
2016	10
2017	7
2018	3
2019	6
2020	2
2021	2
2022	4
2023	9
2024	4
2025	7
2026	17

Applicants with the most clearances

Product code IOR

Applicants holding the most 510(k) clearances under product code IOR
Applicant	Clearances
Invacare GmbH	32
Colours 'N Motion	12
Freedom Designs Inc	10
Sunrise Medical, Inc.	10
Everest & Jennings, Inc.	9
Pdg Product Design Group Inc	8
Labac Systems, Inc.	6
Redman, Inc.	6
Zhenjiang Assure Medical Equipment Co Ltd	6
Etac Us, Inc.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 125 companies shown, in name order