FDA 510(k)

tens & ems设备（TU1080）

K号: K242787 · 2024-12-18

申请人Changsha Anxiang Medical Technology Co., Ltd.

决定日期2024-12-18

产品代码NGX

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决定实质等同

器械摘要

Tens & Ems Device (TU1080) 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 2024-12-18 under 510(k) number K242787. 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 Tens & Ems Device (TU1080)?

Tens & Ems Device (TU1080) is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is Changsha Anxiang Medical Technology Co., Ltd.. The 510(k) number is K242787.

When did Tens & Ems Device (TU1080) receive FDA 510(k) clearance?

Tens & Ems Device (TU1080) received FDA 510(k) clearance on 2024-12-18, under 510(k) number K242787.

Who is the listed applicant for Tens & Ems Device (TU1080)?

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 Tens & Ems Device (TU1080)?

The FDA product code for Tens & Ems Device (TU1080) 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。

K251429OTC 4通道可充电经皮神经电刺激仪 K251706经皮神经电刺激（TENS）和电肌肉刺激单元 K2511873合1经皮神经电刺激仪（TC1241，TC2241，TS1241）K2507593合1经皮神经电刺激仪 K243763无线经皮神经电刺激（TENS）与电肌肉刺激（EMS）单元 K243511OTC TENS & EMS 单位

查看所有 8 个设备 →

官方来源

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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。