高音功率治疗（HiToP）（型号：HiToP PNP）
K号: K252816 · 2026-06-02
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决定日期2026-06-02
产品代码IPF
咨询委员会PM
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
High Tone Power therapy (HiToP) (Model: HiToP PNP) is the device name listed in this FDA 510(k) record. The listed applicant is Mohammadali Nezakati. It received FDA 510(k) clearance on 2026-06-02 under 510(k) number K252816. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the High Tone Power therapy (HiToP) (Model: HiToP PNP)?
High Tone Power therapy (HiToP) (Model: HiToP PNP) is a medical device that received FDA 510(k) clearance on 2026-06-02. The listed applicant is Mohammadali Nezakati. The 510(k) number is K252816.
When did High Tone Power therapy (HiToP) (Model: HiToP PNP) receive FDA 510(k) clearance?
High Tone Power therapy (HiToP) (Model: HiToP PNP) received FDA 510(k) clearance on 2026-06-02, under 510(k) number K252816.
Who is the listed applicant for High Tone Power therapy (HiToP) (Model: HiToP PNP)?
The FDA 510(k) record lists Mohammadali Nezakati as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for High Tone Power therapy (HiToP) (Model: HiToP PNP)?
The FDA product code for High Tone Power therapy (HiToP) (Model: HiToP PNP) is IPF.
相关临床试验
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相关器械（代码：IPF）
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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