FDA 510(k)

手動輪椅（型號 W28）

K 號：K200466 · 2021-06-14

申請人Jiangsu Jumao X-Care Medical Equipment Co., Ltd.

決定日期2021-06-14

產品代碼IOR

諮詢委員會PM

決定相當於

器材摘要

Manual Wheelchair (Model W28) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-06-14 under 510(k) number K200466. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Manual Wheelchair (Model W28)?

Manual Wheelchair (Model W28) is a medical device that received FDA 510(k) clearance on 2021-06-14. The listed applicant is Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. The 510(k) number is K200466.

When did Manual Wheelchair (Model W28) receive FDA 510(k) clearance?

Manual Wheelchair (Model W28) received FDA 510(k) clearance on 2021-06-14, under 510(k) number K200466.

Who is the listed applicant for Manual Wheelchair (Model W28)?

The FDA 510(k) record lists Jiangsu Jumao X-Care Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Manual Wheelchair (Model W28)?

The FDA product code for Manual Wheelchair (Model W28) is IOR.