电动轮椅 (W5915B, W5915C, W5915D)
K号: K253812 · 2026-06-18
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决定日期2026-06-18
产品代码ITI
咨询委员会PM
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决定实质等同
器械摘要
Power Wheelchair (W5915B, W5915C, W5915D) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253812. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Power Wheelchair (W5915B, W5915C, W5915D)?
Power Wheelchair (W5915B, W5915C, W5915D) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. The 510(k) number is K253812.
When did Power Wheelchair (W5915B, W5915C, W5915D) receive FDA 510(k) clearance?
Power Wheelchair (W5915B, W5915C, W5915D) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253812.
Who is the listed applicant for Power Wheelchair (W5915B, W5915C, W5915D)?
FDA 510(k)记录显示，浙江英诺欧康复设备股份有限公司为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for Power Wheelchair (W5915B, W5915C, W5915D)?
The FDA product code for Power Wheelchair (W5915B, W5915C, W5915D) is ITI.
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Zhejiang Innuovo Rehabilitation Devices 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：ITI）
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。
K262582电动轮椅（GP100）Suzhou Green Pine Medical Co., Ltd.K262054电动轮椅Yongkang Joymax Medical Technology Co., Ltd.K260053电动轮椅（OS-R-M01I）Beijing OrionStar Technology Co., Ltd.K260229电动轮椅（HC819N，HC830N，HC831N）Yongkang Hengyi Vehicle Co., Ltd.K261354电动轮椅（D03）Foshan Sowell Medical Technology Co., Ltd.K261149电动轮椅（DY611A-2，DY612A-1）Zhejiang Lumbre Electric Appliance 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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