Mobility Scooter (W3431)
Summary
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd received 510(k) clearance for Mobility Scooter (W3431), a INI device. Cleared on 2024-05-02.
Details
Source
510(k) Clearance
External ID
K240012
Action Date
2024-05-02
Status
Traditional
Category
device
Product Code
INI
Product Description
Mobility Scooter (W3431). Product code: INI.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Zhejiang Innuovo Rehabilitation Devices Co.,Ltd has received 16 total clearances in our database.
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd has 16 FDA actions in our database, including 16 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Zhejiang Innuovo Rehabilitation Devices Co.,Ltd have FDA actions?
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd has 16 FDA actions in our database, including 0 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K240012" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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