Helio Kids; Apex P
K号: K260295 · 2026-05-28
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决定日期2026-05-28
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
Helio Kids; Apex P is the device name listed in this FDA 510(k) record. The listed applicant is Motion Composites. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K260295. 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 Helio Kids; Apex P?
Helio Kids; Apex P is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Motion Composites. The 510(k) number is K260295.
When did Helio Kids; Apex P receive FDA 510(k) clearance?
Helio Kids; Apex P received FDA 510(k) clearance on 2026-05-28, under 510(k) number K260295.
Who is the listed applicant for Helio Kids; Apex P?
The FDA 510(k) record lists Motion Composites as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Helio Kids; Apex P?
The FDA product code for Helio Kids; Apex P 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Motion Composites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.K260145YJ-K1K2 轮椅（YJ-013F）Zhenjiang Assure Medical Equipment Co., Ltd.K260141减重重型轮椅（YJ-010V，YJ-010C）Zhenjiang Assure Medical Equipment Co., Ltd.K260144倾斜轮椅（YJ-013L）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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