Solax 助力轮椅
K号: K182576 · 2019-05-21
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决定日期2019-05-21
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
Solax Powered Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Prestige Sporting Goods Co., Ltd.. It received FDA 510(k) clearance on 2019-05-21 under 510(k) number K182576. 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 Solax Powered Wheelchair?
Solax Powered Wheelchair is a medical device that received FDA 510(k) clearance on 2019-05-21. The listed applicant is Dongguan Prestige Sporting Goods Co., Ltd.. The 510(k) number is K182576.
When did Solax Powered Wheelchair receive FDA 510(k) clearance?
Solax Powered Wheelchair received FDA 510(k) clearance on 2019-05-21, under 510(k) number K182576.
Who is the listed applicant for Solax Powered Wheelchair?
The FDA 510(k) record lists Dongguan Prestige Sporting Goods Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Solax Powered Wheelchair?
The FDA product code for Solax Powered Wheelchair 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Dongguan Prestige Sporting Goods 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。
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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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