Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF)
Summary
Zhenjiang Assure Medical Equipment Co., Ltd. received 510(k) clearance for Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF), a IOR device. Cleared on 2023-09-15.
Details
Source
510(k) Clearance
External ID
K232198
Action Date
2023-09-15
Status
Traditional
Category
device
Product Code
IOR
Product Description
Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF). Product code: IOR.
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. Zhenjiang Assure Medical Equipment Co., Ltd. has received 5 total clearances in our database.
Zhenjiang Assure Medical Equipment Co., Ltd. has 5 FDA actions in our database, including 5 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 Zhenjiang Assure Medical Equipment Co., Ltd. have FDA actions?
Zhenjiang Assure Medical Equipment Co., Ltd. has 5 FDA actions in our database, including 0 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K232198" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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