FDA product code INI: Vehicle, Motorized 3-Wheeled
INI is the FDA product code for vehicle, motorized 3-wheeled. It is a Class II device, regulated under 21 CFR 890.3800 and reviewed by the Physical Medicine panel. FDA has cleared 352 510(k) submissions under INI, 56 in the last five years, from 134 different applicants. The average 510(k) review took 119 days (median 76); 144 days on average over the last three years. FDA has posted 22 recalls for INI devices.
Classification
| Field | Value |
|---|---|
| Device name | Vehicle, Motorized 3-Wheeled |
| Device class | Class II |
| Regulation | 21 CFR 890.3800 |
| 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 INI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 188 |
| 2018 | 3 | 270 |
| 2019 | 4 | 254 |
| 2020 | 1 | 483 |
| 2021 | 5 | 513 |
| 2022 | 6 | 282 |
| 2023 | 9 | 136 |
| 2024 | 8 | 155 |
| 2025 | 15 | 134 |
| 2026 | 18 | 143 |
Compare with all 510(k) review times · Search every INI clearance
Top INI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wu'S Tech Co., Ltd. | 16 | 2020-12-21 |
| Heartway Medical Products Co., Ltd. | 15 | 2022-10-12 |
| Pride Health Care, Inc. | 14 | 1996-02-12 |
| Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 11 | 2026-08-10 |
| C.T.M. Homecare Product, Inc. | 11 | 2011-04-22 |
129 more applicants have INI clearances. See the full list in Caduvo.
Most recent INI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261859 | Anhui JBH Medical Apparatus Co., Ltd. | Electric Scooter (FDB08, FDB08A, FDB12) | 2026-09-19 | 107 |
| K260094 | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Mobility Scooter (W3465, W3902 (S50 Carbon)) | 2026-08-10 | 209 |
| K260176 | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Mobility Scooter (W3483, W3483A) | 2026-08-10 | 201 |
| K261232 | Jochu Technology Co., Ltd. | IERO Mobility Scooter (IERO-01) | 2026-07-14 | 90 |
| K261163 | Yongkang Ruihe Metal Product Co., Ltd. | Mobility Scooter (R200) | 2026-07-07 | 89 |
Recalls for INI devices
22 product recalls in 14 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-04-01.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code INI?
INI is the FDA product code for vehicle, motorized 3-wheeled. It is a Class II device, regulated under 21 CFR 890.3800 and reviewed by the Physical Medicine panel.
What device class is INI?
Class II, regulation 21 CFR 890.3800. Typical premarket route: 510(k).
How long does a 510(k) take for product code INI?
Across 352 cleared submissions the average was 119 days from receipt to decision (median 76).
Which companies have the most INI clearances?
Wu'S Tech Co., Ltd. (16); Heartway Medical Products Co., Ltd. (15); Pride Health Care, Inc. (14); Zhejiang Innuovo Rehabilitation Devices Co.,Ltd (11); C.T.M. Homecare Product, Inc. (11).
Have INI devices been recalled?
Yes: 22 product recalls across 14 recall events; the most recent began 2021-04-01.
Next steps
- Run an FDA pathway report with predicate devices for product code INI
- Run a recall and safety report across every INI manufacturer
- Watch product code INI 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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