OTC TENS & EMS 单位
K号: K243511 · 2025-02-10
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决定日期2025-02-10
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
OTC TENS & EMS 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 2025-02-10 under 510(k) number K243511. 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 OTC TENS & EMS Unit?
OTC TENS & EMS Unit is a medical device that received FDA 510(k) clearance on 2025-02-10. The listed applicant is Changsha Anxiang Medical Technology Co., Ltd.. The 510(k) number is K243511.
When did OTC TENS & EMS Unit receive FDA 510(k) clearance?
OTC TENS & EMS Unit received FDA 510(k) clearance on 2025-02-10, under 510(k) number K243511.
Who is the listed applicant for OTC TENS & EMS 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 OTC TENS & EMS Unit?
The FDA product code for OTC TENS & EMS 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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