ITIClass II
Wheelchair, Powered
21 CFR 890.3860 / Physical Medicine
ITI is the FDA product code for Wheelchair, Powered, a class II device type, regulated under 21 CFR 890.3860. FDA's definition for this code reads: "A powered wheelchair is a battery-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 , FDA records hold 586 510(k) clearances under this code, the most recent dated , and 71 recalls.
Classification record
- Product code
- ITI
- Device name
- Wheelchair, Powered
- FDA definition
- A powered wheelchair is a battery-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 require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).
- Regulation
- 21 CFR 890.3860
- 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
- Yes
- Ingested clearances
- 590
- Ingested recalls
- 71
Clearances, product code ITI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 3 |
| 1980 | 2 |
| 1981 | 2 |
| 1982 | 2 |
| 1983 | 3 |
| 1984 | 6 |
| 1985 | 17 |
| 1986 | 7 |
| 1987 | 19 |
| 1988 | 22 |
| 1989 | 9 |
| 1990 | 15 |
| 1991 | 14 |
| 1992 | 7 |
| 1993 | 3 |
| 1994 | 30 |
| 1995 | 8 |
| 1996 | 10 |
| 1997 | 16 |
| 1998 | 10 |
| 1999 | 19 |
| 2000 | 16 |
| 2001 | 26 |
| 2002 | 23 |
| 2003 | 25 |
| 2004 | 26 |
| 2005 | 14 |
| 2006 | 8 |
| 2007 | 18 |
| 2008 | 9 |
| 2009 | 7 |
| 2010 | 6 |
| 2011 | 4 |
| 2012 | 6 |
| 2013 | 5 |
| 2014 | 5 |
| 2015 | 10 |
| 2016 | 6 |
| 2017 | 4 |
| 2018 | 4 |
| 2019 | 3 |
| 2020 | 6 |
| 2021 | 13 |
| 2022 | 16 |
| 2023 | 8 |
| 2024 | 38 |
| 2025 | 29 |
| 2026 | 30 |
Applicants with the most clearances
Product code ITI| Applicant | Clearances |
|---|---|
| Invacare GmbH | 38 |
| Fortress Scientific, Ltd. | 19 |
| Everest & Jennings, Inc. | 17 |
| Hoveround Corp. | 15 |
| Permobil, AB | 13 |
| Sunrise Medical, Inc. | 13 |
| Merits Health Products, Inc. | 10 |
| A-Bec Mobility, Inc. | 9 |
| Imc-Heart Way LLC | 9 |
| Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | 9 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.