经皮神经电刺激（TENS）和电肌肉刺激单元
K号: K251706 · 2025-07-30
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决定日期2025-07-30
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
TENS and 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 2025-07-30 under 510(k) number K251706. 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 and EMS Unit?
TENS and EMS Unit is a medical device that received FDA 510(k) clearance on 2025-07-30. The listed applicant is Changsha Anxiang Medical Technology Co., Ltd.. The 510(k) number is K251706.
When did TENS and EMS Unit receive FDA 510(k) clearance?
TENS and EMS Unit received FDA 510(k) clearance on 2025-07-30, under 510(k) number K251706.
Who is the listed applicant for TENS and 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 TENS and EMS Unit?
The FDA product code for TENS and 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。
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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