FDA 510(k)

手动轮椅（W45）

K号: K252825 · 2025-12-05

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

决定日期2025-12-05

产品代码IOR

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决定实质等同

器械摘要

Manual Wheelchair (W45) 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 2025-12-05 under 510(k) number K252825. 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 (W45)?

Manual Wheelchair (W45) is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.. The 510(k) number is K252825.

When did Manual Wheelchair (W45) receive FDA 510(k) clearance?

Manual Wheelchair (W45) received FDA 510(k) clearance on 2025-12-05, under 510(k) number K252825.

Who is the listed applicant for Manual Wheelchair (W45)?

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 (W45)?

The FDA product code for Manual Wheelchair (W45) 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）K251130便携式制氧机（JM-P50A）K232783电动轮椅 (型号：JMPW-01W)K230969氧气浓缩器

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。