PlasmaFlow X 压缩袖装置 (XPF0001)
K号: K251446 · 2025-09-17
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申请人Manamed, LLC
决定日期2025-09-17
产品代码JOW
咨询委员会CV
请注意，由于原文未提供具体内容，以下是一个示例翻译：
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产品名称：[产品名称]
公司名称：[公司名称]
FDA批准号：[FDA批准号]
510(k)申请号：[510(k)申请号]
PMA申请号：[PMA申请号]
临床试验注册号：[NCT]
PubMed ID：[PMID]
产品标识符：[标识符]
产品URL：[URL]
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请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同
器械摘要
PlasmaFlow X Compression Sleeve Device (XPF0001) is the device name listed in this FDA 510(k) record. The listed applicant is Manamed, LLC. It received FDA 510(k) clearance on 2025-09-17 under 510(k) number K251446. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PlasmaFlow X Compression Sleeve Device (XPF0001)?
PlasmaFlow X Compression Sleeve Device (XPF0001) is a medical device that received FDA 510(k) clearance on 2025-09-17. The listed applicant is Manamed, LLC. The 510(k) number is K251446.
When did PlasmaFlow X Compression Sleeve Device (XPF0001) receive FDA 510(k) clearance?
PlasmaFlow X Compression Sleeve Device (XPF0001) received FDA 510(k) clearance on 2025-09-17, under 510(k) number K251446.
Who is the listed applicant for PlasmaFlow X Compression Sleeve Device (XPF0001)?
FDA 510(k)记录中列出了Manamed, LLC为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for PlasmaFlow X Compression Sleeve Device (XPF0001)?
The FDA product code for PlasmaFlow X Compression Sleeve Device (XPF0001) is JOW.
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Manamed, LLC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：JOW）
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。
K261807顺序循环器（SC-4004-DL，SC-4008-DL）Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus 高级气动压缩系统Tactile MedicalK253386DVT 服装Vistar Medical Supplies Co., Ltd.K250242压缩治疗设备（LGT-2202DVT）Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , 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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