Tyece OTC EMS 系统
K号: K183454 · 2019-02-26
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申请人Tyece , Ltd.
决定日期2019-02-26
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
Tyece OTC EMS System is the device name listed in this FDA 510(k) record. The listed applicant is Tyece , Ltd.. It received FDA 510(k) clearance on 2019-02-26 under 510(k) number K183454. 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 Tyece OTC EMS System?
Tyece OTC EMS System is a medical device that received FDA 510(k) clearance on 2019-02-26. The listed applicant is Tyece , Ltd.. The 510(k) number is K183454.
When did Tyece OTC EMS System receive FDA 510(k) clearance?
Tyece OTC EMS System received FDA 510(k) clearance on 2019-02-26, under 510(k) number K183454.
Who is the listed applicant for Tyece OTC EMS System?
The FDA 510(k) record lists Tyece , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tyece OTC EMS System?
The FDA product code for Tyece OTC EMS System is NGX.
相关临床试验
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列明Tyece , 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
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