经皮神经电刺激与经皮肌肉刺激
K号: K201354 · 2020-12-11
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决定日期2020-12-11
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
TENS & PMS is the device name listed in this FDA 510(k) record. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. It received FDA 510(k) clearance on 2020-12-11 under 510(k) number K201354. 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 & PMS?
TENS & PMS is a medical device that received FDA 510(k) clearance on 2020-12-11. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K201354.
When did TENS & PMS receive FDA 510(k) clearance?
TENS & PMS received FDA 510(k) clearance on 2020-12-11, under 510(k) number K201354.
Who is the listed applicant for TENS & PMS?
The FDA 510(k) record lists Hong Qiangxing (Shenzhen) Electronics Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TENS & PMS?
The FDA product code for TENS & PMS is NGX.
列明Hong Qiangxing (Shenzhen) Electronics Limited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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