健身腰带（型号：KLT-07）
K号: K231136 · 2023-06-16
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决定日期2023-06-16
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
Fitness Belt (Model: KLT-07) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kelutongda Industrial Co., Ltd.. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K231136. 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 Fitness Belt (Model: KLT-07)?
Fitness Belt (Model: KLT-07) is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Shenzhen Kelutongda Industrial Co., Ltd.. The 510(k) number is K231136.
When did Fitness Belt (Model: KLT-07) receive FDA 510(k) clearance?
Fitness Belt (Model: KLT-07) received FDA 510(k) clearance on 2023-06-16, under 510(k) number K231136.
Who is the listed applicant for Fitness Belt (Model: KLT-07)?
The FDA 510(k) record lists Shenzhen Kelutongda Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fitness Belt (Model: KLT-07)?
The FDA product code for Fitness Belt (Model: KLT-07) 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。
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
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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