3合1经皮神经电刺激仪
K号: K250759 · 2025-06-13
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决定日期2025-06-13
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
3 in 1 TENS UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Changsha Anxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-06-13 under 510(k) number K250759. 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 3 in 1 TENS UNIT?
3 in 1 TENS UNIT is a medical device that received FDA 510(k) clearance on 2025-06-13. The listed applicant is Changsha Anxiang Medical Technology Co., Ltd.. The 510(k) number is K250759.
When did 3 in 1 TENS UNIT receive FDA 510(k) clearance?
3 in 1 TENS UNIT received FDA 510(k) clearance on 2025-06-13, under 510(k) number K250759.
Who is the listed applicant for 3 in 1 TENS UNIT?
The FDA 510(k) record lists Changsha Anxiang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 3 in 1 TENS UNIT?
The FDA product code for 3 in 1 TENS UNIT is NGX.
列明Changsha Anxiang 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。
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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