手动轮椅（SYIV100A008）
K号: K252517 · 2025-10-03
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决定日期2025-10-03
产品代码IOR
咨询委员会PM
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决定实质等同
器械摘要
Manual Wheelchair (SYIV100A008) is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Shenyu Medical Equipment Co.,Ltd. It received FDA 510(k) clearance on 2025-10-03 under 510(k) number K252517. 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 (SYIV100A008)?
Manual Wheelchair (SYIV100A008) is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is Ningbo Shenyu Medical Equipment Co.,Ltd. The 510(k) number is K252517.
When did Manual Wheelchair (SYIV100A008) receive FDA 510(k) clearance?
Manual Wheelchair (SYIV100A008) received FDA 510(k) clearance on 2025-10-03, under 510(k) number K252517.
Who is the listed applicant for Manual Wheelchair (SYIV100A008)?
The FDA 510(k) record lists Ningbo Shenyu 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 (SYIV100A008)?
The FDA product code for Manual Wheelchair (SYIV100A008) is IOR.
相关临床试验
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。
列明Ningbo Shenyu 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。
相关器械（代码：IOR）
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。
K253762ErgoSteel（ES0001/696）Strongback Mobility AG C/O Blueaudit GmbHK261919多功能轮椅（YJ-059）Zhenjiang Assure Medical Equipment Co., Ltd.K260144倾斜轮椅（YJ-013L）Zhenjiang Assure Medical Equipment Co., Ltd.K260141减重重型轮椅（YJ-010V，YJ-010C）Zhenjiang Assure Medical Equipment Co., Ltd.K260145YJ-K1K2 轮椅（YJ-013F）Zhenjiang Assure Medical Equipment Co., Ltd.K261571手动轮椅（H008，PCK7）Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
官方来源
在 FDA 数据库中查看 →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。
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