无线经皮神经电刺激（TENS）与电肌肉刺激（EMS）单元
K号: K243763 · 2025-03-12
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决定日期2025-03-12
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
Wireless 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 2025-03-12 under 510(k) number K243763. 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 Wireless TENS & EMS Unit?
Wireless TENS & EMS Unit is a medical device that received FDA 510(k) clearance on 2025-03-12. The listed applicant is Changsha Anxiang Medical Technology Co., Ltd.. The 510(k) number is K243763.
When did Wireless TENS & EMS Unit receive FDA 510(k) clearance?
Wireless TENS & EMS Unit received FDA 510(k) clearance on 2025-03-12, under 510(k) number K243763.
Who is the listed applicant for Wireless 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 Wireless TENS & EMS Unit?
The FDA product code for Wireless TENS & EMS Unit is NGX.
相关临床试验
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。
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。
K253790高强度聚焦电磁刺激装置（FE60）Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max（电脉冲治疗仪）Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK252154便携式电刺激治疗设备（LGT-2320BE，LGT-2320ME，和LGT-2320SP）Guangzhou Longest Medical Technology Co., Ltd.K253478Motive®腰背肌刺激器（OT01-1003）Motive Health, Inc.
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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