FDA 510(k)

肌肉刺激器设备（PZ-100）

K号: K250038 · 2025-05-19

申请人Zhengzhou PZ Laser Slim Technology Co., Ltd.

决定日期2025-05-19

产品代码NGX

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

Muscle Stimulator Device (PZ-100) is the device name listed in this FDA 510(k) record. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-19 under 510(k) number K250038. 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 Muscle Stimulator Device (PZ-100)?

Muscle Stimulator Device (PZ-100) is a medical device that received FDA 510(k) clearance on 2025-05-19. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K250038.

When did Muscle Stimulator Device (PZ-100) receive FDA 510(k) clearance?

Muscle Stimulator Device (PZ-100) received FDA 510(k) clearance on 2025-05-19, under 510(k) number K250038.

Who is the listed applicant for Muscle Stimulator Device (PZ-100)?

FDA 510(k)记录将郑州普泽激光瘦身科技有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Muscle Stimulator Device (PZ-100)?

The FDA product code for Muscle Stimulator Device (PZ-100) is NGX.

列明Zhengzhou PZ Laser Slim Technology Co., 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。

K261817二极管激光治疗系统（PZ-BDT67-01，PZ-BDT67-02）K2615891927nm 钥元素激光系统（PZ-DJG85-01，PZ-DJG85-02）K261582真空滚轮射频瘦身设备（医疗用途）（PZ-FY66-01，PZ-FY66-02）K2618211565nm 激光治疗设备（PZ-JG86-01，PZ-JG86-02）K2527321927nm钥激光系统（PZ-DJG75-01，PZ-DJG75-02）K251339医疗二极管激光脱毛设备（PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04）

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官方来源

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