Pure Impact
K号: K251746 · 2025-07-02
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决定日期2025-07-02
产品代码NGX
咨询委员会PM
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决定实质等同
器械摘要
Pure Impact is the device name listed in this FDA 510(k) record. The listed applicant is Sofwave Medical, Ltd.. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K251746. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Pure Impact?
Pure Impact is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Sofwave Medical, Ltd.. The 510(k) number is K251746.
When did Pure Impact receive FDA 510(k) clearance?
Pure Impact received FDA 510(k) clearance on 2025-07-02, under 510(k) number K251746.
Who is the listed applicant for Pure Impact?
The FDA 510(k) record lists Sofwave Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pure Impact?
The FDA product code for Pure Impact is NGX.
相关临床试验
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列明Sofwave Medical, Ltd.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：NGX）
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
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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