e-motion M25
K号: K221215 · 2022-05-24
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申请人Alber GmbH
决定日期2022-05-24
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
e-motion M25 is the device name listed in this FDA 510(k) record. The listed applicant is Alber GmbH. It received FDA 510(k) clearance on 2022-05-24 under 510(k) number K221215. 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 e-motion M25?
e-motion M25 is a medical device that received FDA 510(k) clearance on 2022-05-24. The listed applicant is Alber GmbH. The 510(k) number is K221215.
When did e-motion M25 receive FDA 510(k) clearance?
e-motion M25 received FDA 510(k) clearance on 2022-05-24, under 510(k) number K221215.
Who is the listed applicant for e-motion M25?
The FDA 510(k) record lists Alber GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for e-motion M25?
The FDA product code for e-motion M25 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Alber GmbH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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