FDA 510(k)

便携式电刺激治疗设备（LGT-2320BE，LGT-2320ME，和LGT-2320SP）

K号: K252154 · 2025-12-09

申请人Guangzhou Longest Medical Technology Co., Ltd.

决定日期2025-12-09

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

Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Longest Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-09 under 510(k) number K252154. 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 Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)?

Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) is a medical device that received FDA 510(k) clearance on 2025-12-09. The listed applicant is Guangzhou Longest Medical Technology Co., Ltd.. The 510(k) number is K252154.

When did Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) receive FDA 510(k) clearance?

Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) received FDA 510(k) clearance on 2025-12-09, under 510(k) number K252154.

Who is the listed applicant for Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)?

The FDA 510(k) record lists Guangzhou Longest Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)?

The FDA product code for Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) is NGX.

列明Guangzhou Longest Medical 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。

K250242压缩治疗设备（LGT-2202DVT）K250244压缩治疗设备（LGT-2210DS）

官方来源

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