Flexx Junior（FLX-J00，FLX-J50）
K号: K250576 · 2025-11-04
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决定日期2025-11-04
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
Flexx Junior (FLX-J00, FLX-J50) is the device name listed in this FDA 510(k) record. The listed applicant is Karma Mobility Co, Ltd.. It received FDA 510(k) clearance on 2025-11-04 under 510(k) number K250576. 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 Flexx Junior (FLX-J00, FLX-J50)?
Flexx Junior (FLX-J00, FLX-J50) is a medical device that received FDA 510(k) clearance on 2025-11-04. The listed applicant is Karma Mobility Co, Ltd.. The 510(k) number is K250576.
When did Flexx Junior (FLX-J00, FLX-J50) receive FDA 510(k) clearance?
Flexx Junior (FLX-J00, FLX-J50) received FDA 510(k) clearance on 2025-11-04, under 510(k) number K250576.
Who is the listed applicant for Flexx Junior (FLX-J00, FLX-J50)?
The FDA 510(k) record lists Karma Mobility Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Flexx Junior (FLX-J00, FLX-J50)?
The FDA product code for Flexx Junior (FLX-J00, FLX-J50) is IOR.
相关临床试验
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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。
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官方来源
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