RecallHawk

Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-01

Zhenjiang Assure Medical Equipment Co., Ltd.

Summary

Zhenjiang Assure Medical Equipment Co., Ltd. received 510(k) clearance for Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE), a IOR device. Cleared on 2023-09-15.

Details

Source

510(k) Clearance

External ID

K232199

Action Date

2023-09-15

Status

Traditional

Category

device

Product Code

IOR

Product Description

Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE). Product code: IOR.

Company

Zhenjiang Assure Medical Equipment Co., Ltd.

Context & Analysis

A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 389 device clearances issued this month. Zhenjiang Assure Medical Equipment Co., Ltd. has received 6 total clearances in our database.

Zhenjiang Assure Medical Equipment Co., Ltd. has 6 FDA actions in our database, including 6 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 6 FDA actions in our database, including 0 recalls and 6 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "K232199" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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