EdgeFlow 凝胶垫
K号: K252337 · 2026-04-24
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器械摘要
EdgeFlow Gel Pad is the device name listed in this FDA 510(k) record. The listed applicant is Edgecare, Inc.. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K252337. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EdgeFlow Gel Pad?
EdgeFlow Gel Pad is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Edgecare, Inc.. The 510(k) number is K252337.
When did EdgeFlow Gel Pad receive FDA 510(k) clearance?
EdgeFlow Gel Pad received FDA 510(k) clearance on 2026-04-24, under 510(k) number K252337.
Who is the listed applicant for EdgeFlow Gel Pad?
The FDA 510(k) record lists Edgecare, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EdgeFlow Gel Pad?
The FDA product code for EdgeFlow Gel Pad is MUI.
相关临床试验
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列明Edgecare, Inc.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：MUI）
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。
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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