FDA product code IOR: Wheelchair, Mechanical
IOR is the FDA product code for wheelchair, mechanical. It is a Class I device, regulated under 21 CFR 890.3850 and reviewed by the Physical Medicine panel. FDA has cleared 467 510(k) submissions under IOR, 40 in the last five years, from 265 different applicants. The average 510(k) review took 80 days (median 46); 124 days on average over the last three years. FDA has posted 40 recalls for IOR devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Wheelchair, Mechanical |
| Device class | Class I |
| Regulation | 21 CFR 890.3850 |
| 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 IOR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 199 |
| 2018 | 3 | 163 |
| 2019 | 6 | 208 |
| 2020 | 2 | 211 |
| 2021 | 2 | 414 |
| 2022 | 4 | 306 |
| 2023 | 9 | 247 |
| 2024 | 4 | 88 |
| 2025 | 7 | 138 |
| 2026 | 16 | 145 |
Compare with all 510(k) review times · Search every IOR clearance
Top IOR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Invacare Corp. | 24 | 2001-08-03 |
| Colours 'N Motion | 12 | 2007-07-27 |
| Zhenjiang Assure Medical Equipment Co., Ltd. | 10 | 2026-09-16 |
| Freedom Designs, Inc. | 10 | 2015-10-22 |
| Everest & Jennings, Inc. | 9 | 1994-02-17 |
260 more applicants have IOR clearances. See the full list in Caduvo.
Most recent IOR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261919 | Zhenjiang Assure Medical Equipment Co., Ltd. | Multifunctional wheelchair (YJ-059) | 2026-09-16 | 99 |
| K260144 | Zhenjiang Assure Medical Equipment Co., Ltd. | Reclining wheelchair (YJ-013L) | 2026-09-15 | 238 |
| K260141 | Zhenjiang Assure Medical Equipment Co., Ltd. | Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C) | 2026-09-15 | 238 |
| K260145 | Zhenjiang Assure Medical Equipment Co., Ltd. | YJ-K1K2 Wheelchair (YJ-013F) | 2026-09-15 | 238 |
| K261571 | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Manual Wheelchair (H008, PCK7) | 2026-08-06 | 86 |
Recalls for IOR devices
40 product recalls in 26 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-09-24.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code IOR?
IOR is the FDA product code for wheelchair, mechanical. It is a Class I device, regulated under 21 CFR 890.3850 and reviewed by the Physical Medicine panel.
What device class is IOR?
Class I, regulation 21 CFR 890.3850. Typical premarket route: 510(k).
How long does a 510(k) take for product code IOR?
Across 467 cleared submissions the average was 80 days from receipt to decision (median 46).
Which companies have the most IOR clearances?
Invacare Corp. (24); Colours 'N Motion (12); Zhenjiang Assure Medical Equipment Co., Ltd. (10); Freedom Designs, Inc. (10); Everest & Jennings, Inc. (9).
Have IOR devices been recalled?
Yes: 40 product recalls across 26 recall events; the most recent began 2021-09-24.
Next steps
- Run an FDA pathway report with predicate devices for product code IOR
- Run a recall and safety report across every IOR manufacturer
- Watch product code IOR 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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