FDA 510(k)

手动轮椅（型号W28）

K号: K200466 · 2021-06-14

申请人Jiangsu Jumao X-Care Medical Equipment Co., Ltd.

决定日期2021-06-14

产品代码IOR

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决定实质等同

器械摘要

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.

常见问题

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.

列明Jiangsu Jumao X-Care Medical Equipment Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250964便携式痰液吸引器（JMA D01）K253632手动轮椅（W50）K252828手动轮椅（W47）K252825手动轮椅（W45）K251130便携式制氧机（JM-P50A）K232783电动轮椅 (型号：JMPW-01W)

查看所有 8 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。