Frontier系列电动轮椅
K号: K213090 · 2021-11-19
广告
决定日期2021-11-19
产品代码ITI
咨询委员会PM
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Frontier Series Power Wheelchairs is the device name listed in this FDA 510(k) record. The listed applicant is Magic Mobility. It received FDA 510(k) clearance on 2021-11-19 under 510(k) number K213090. 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 Frontier Series Power Wheelchairs?
Frontier Series Power Wheelchairs is a medical device that received FDA 510(k) clearance on 2021-11-19. The listed applicant is Magic Mobility. The 510(k) number is K213090.
When did Frontier Series Power Wheelchairs receive FDA 510(k) clearance?
Frontier Series Power Wheelchairs received FDA 510(k) clearance on 2021-11-19, under 510(k) number K213090.
Who is the listed applicant for Frontier Series Power Wheelchairs?
The FDA 510(k) record lists Magic Mobility as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Frontier Series Power Wheelchairs?
The FDA product code for Frontier Series Power Wheelchairs 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Magic Mobility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。
广告