Gnesis EMS Plus
K号: K230261 · 2023-06-06
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决定日期2023-06-06
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
Gnesis EMS Plus is the device name listed in this FDA 510(k) record. The listed applicant is Creative Fitness Developments S.L.. It received FDA 510(k) clearance on 2023-06-06 under 510(k) number K230261. 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 Gnesis EMS Plus?
Gnesis EMS Plus is a medical device that received FDA 510(k) clearance on 2023-06-06. The listed applicant is Creative Fitness Developments S.L.. The 510(k) number is K230261.
When did Gnesis EMS Plus receive FDA 510(k) clearance?
Gnesis EMS Plus received FDA 510(k) clearance on 2023-06-06, under 510(k) number K230261.
Who is the listed applicant for Gnesis EMS Plus?
The FDA 510(k) record lists Creative Fitness Developments S.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Gnesis EMS Plus?
The FDA product code for Gnesis EMS Plus is NGX.
相关临床试验
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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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