Product code INI: 510(k) clearances and predicates
Product code INI covers Electric Scooter (FNS01,FNS03). FDA lists 353 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
353 clearances on file under product code INI. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 6 |
| 2023 | 9 |
| 2024 | 8 |
| 2025 | 15 |
| 2026 so far | 19 |
Recent clearances
Newest INI clearances in the FDA index, with applicant and decision date:
- K261078, Electric Scooter (FNS01,FNS03), applicant Anhui Jbh Medical Apparatus Co., Ltd., decided 2026-09-24. FDA record
- K261859, Electric Scooter (FDB08, FDB08A, FDB12), applicant Anhui JBH Medical Apparatus Co., Ltd., decided 2026-09-19. FDA record
- K260176, Mobility Scooter (W3483, W3483A), applicant Zhejiang Innuovo Rehabilitation Devices Co.,Ltd, decided 2026-08-10. FDA record
- K260094, Mobility Scooter (W3465, W3902 (S50 Carbon)), applicant Zhejiang Innuovo Rehabilitation Devices Co.,Ltd, decided 2026-08-10. FDA record
- K261232, IERO Mobility Scooter (IERO-01), applicant Jochu Technology Co., Ltd., decided 2026-07-14. FDA record
- K261163, Mobility Scooter (R200), applicant Yongkang Ruihe Metal Product Co., Ltd., decided 2026-07-07. FDA record
- K253257, Virgo Mobility Scooter (Virgo-D,Virgo-F), applicant Jiangsu Intco Medical Products Co., Ltd., decided 2026-06-08. FDA record
- K253600, Scooter (YD-03), applicant Yurob Rehabilitation Medical Co., Ltd., decided 2026-06-03. 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 Scooter (FDB08, FDB08A, FDB12), Mobility Scooter (W3483, W3483A). Watch new INI 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 INI?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent INI clearances include Electric Scooter (FNS01,FNS03).
How many 510(k) clearances use product code INI?
353 at the time this page was generated, from openFDA records.
How do I find a predicate device under INI?
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 INI clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
Get this for INI, every week.
$49/month. Unlimited codes, one seat covers every client. Cancel anytime.
7-day free trial on the monthly plan. Card required, pay nothing for 7 days. 7-day money-back guarantee. Secure checkout via Stripe.
Not ready? Get one free INI brief
Tell us where to send it. No card required.
You are on the list.
We will email your free INI brief shortly. INI is already in your watchlist draft. Want the ongoing watch instead of one brief? See the 7-day free trial.
Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.