Product code ITI: 510(k) clearances and predicates
Product code ITI covers Electric Wheelchair. FDA lists 590 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
590 clearances on file under product code ITI. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 16 |
| 2023 | 8 |
| 2024 | 38 |
| 2025 | 29 |
| 2026 so far | 30 |
Recent clearances
Newest ITI clearances in the FDA index, with applicant and decision date:
- K262582, Electric wheelchair (GP100), applicant Suzhou Green Pine Medical Co., Ltd., decided 2026-09-23. FDA record
- K262054, Electric Wheelchair, applicant Yongkang Joymax Medical Technology Co., Ltd., decided 2026-09-16. FDA record
- K260229, Electric wheelchair (HC819N, HC830N, HC831N), applicant Yongkang Hengyi Vehicle Co., Ltd., decided 2026-09-08. FDA record
- K260053, Power Wheelchair (OS-R-M01I), applicant Beijing OrionStar Technology Co., Ltd., decided 2026-09-08. FDA record
- K261354, Electric wheelchair (D03), applicant Foshan Sowell Medical Technology Co., Ltd., decided 2026-08-21. FDA record
- K261149, Electric Wheelchair (DY611A-2, DY612A-1), applicant Zhejiang Lumbre Electric Appliance Co., Ltd., decided 2026-07-10. FDA record
- K261396, Electric Wheelchair, applicant Ningbo Resshidi Medical Devices Co., Ltd., decided 2026-07-08. FDA record
- K261164, Electric wheelchair (XW-LY007 ), applicant Yongkang Ruihe Metal Product Co., Ltd., decided 2026-07-07. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Electric wheelchair (GP100), Electric wheelchair (HC819N, HC830N, HC831N). Watch new ITI clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code ITI?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent ITI clearances include Electric Wheelchair.
How many 510(k) clearances use product code ITI?
590 at the time this page was generated, from openFDA records.
How do I find a predicate device under ITI?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new ITI clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.