FDA product code ITI: Wheelchair, Powered
ITI is the FDA product code for wheelchair, powered. It is a Class II device, regulated under 21 CFR 890.3860 and reviewed by the Physical Medicine panel. FDA has cleared 589 510(k) submissions under ITI, 120 in the last five years, from 263 different applicants. The average 510(k) review took 122 days (median 87); 129 days on average over the last three years. FDA has posted 71 recalls for ITI devices, 28 initiated in the last five years.
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).
Classification
| Field | Value |
|---|---|
| Device name | Wheelchair, Powered |
| Device class | Class II |
| Regulation | 21 CFR 890.3860 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for ITI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 220 |
| 2018 | 4 | 106 |
| 2019 | 3 | 221 |
| 2020 | 6 | 324 |
| 2021 | 13 | 256 |
| 2022 | 16 | 170 |
| 2023 | 8 | 247 |
| 2024 | 38 | 130 |
| 2025 | 29 | 121 |
| 2026 | 29 | 135 |
Compare with all 510(k) review times · Search every ITI clearance
Top ITI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Invacare Corp. | 32 | 2004-06-04 |
| Fortress Scientific , Ltd. | 19 | 1994-03-28 |
| Everest & Jennings, Inc. | 17 | 1994-03-28 |
| Hoveround Corp. | 15 | 2013-05-07 |
| Permobil AB | 11 | 2015-03-27 |
258 more applicants have ITI clearances. See the full list in Caduvo.
Most recent ITI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262054 | Yongkang Joymax Medical Technology Co., Ltd. | Electric Wheelchair | 2026-09-16 | 90 |
| K260053 | Beijing OrionStar Technology Co., Ltd. | Power Wheelchair (OS-R-M01I) | 2026-09-08 | 243 |
| K260229 | Yongkang Hengyi Vehicle Co., Ltd. | Electric wheelchair (HC819N, HC830N, HC831N) | 2026-09-08 | 225 |
| K261354 | Foshan Sowell Medical Technology Co., Ltd. | Electric wheelchair (D03) | 2026-08-21 | 119 |
| K261149 | Zhejiang Lumbre Electric Appliance Co., Ltd. | Electric Wheelchair (DY611A-2, DY612A-1) | 2026-07-10 | 93 |
Recalls for ITI devices
71 product recalls in 41 recall events; 28 initiated in the last five years and 29 still open. Most recent: 2026-06-25.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 4 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 3 |
| 2025 | 6 |
| 2026 | 13 |
Frequently asked questions
What is FDA product code ITI?
ITI is the FDA product code for wheelchair, powered. It is a Class II device, regulated under 21 CFR 890.3860 and reviewed by the Physical Medicine panel.
What device class is ITI?
Class II, regulation 21 CFR 890.3860. Typical premarket route: 510(k).
How long does a 510(k) take for product code ITI?
Across 589 cleared submissions the average was 122 days from receipt to decision (median 87).
Which companies have the most ITI clearances?
Invacare Corp. (32); Fortress Scientific , Ltd. (19); Everest & Jennings, Inc. (17); Hoveround Corp. (15); Permobil AB (11).
Have ITI devices been recalled?
Yes: 71 product recalls across 41 recall events; the most recent began 2026-06-25.
Next steps
- Run an FDA pathway report with predicate devices for product code ITI
- Run a recall and safety report across every ITI manufacturer
- Watch product code ITI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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