优康（K-UNICARE-USA）
K号: K230983 · 2023-10-20
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决定日期2023-10-20
产品代码KPI
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
Unicare (K-UNICARE-USA) is the device name listed in this FDA 510(k) record. The listed applicant is Tenscare, Ltd.. It received FDA 510(k) clearance on 2023-10-20 under 510(k) number K230983. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Unicare (K-UNICARE-USA)?
Unicare (K-UNICARE-USA) is a medical device that received FDA 510(k) clearance on 2023-10-20. The listed applicant is Tenscare, Ltd.. The 510(k) number is K230983.
When did Unicare (K-UNICARE-USA) receive FDA 510(k) clearance?
Unicare (K-UNICARE-USA) received FDA 510(k) clearance on 2023-10-20, under 510(k) number K230983.
Who is the listed applicant for Unicare (K-UNICARE-USA)?
The FDA 510(k) record lists Tenscare, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Unicare (K-UNICARE-USA)?
The FDA product code for Unicare (K-UNICARE-USA) is KPI.
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。
列明Tenscare, 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：KPI）
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。
K262353BTL-299-FBTL Industries, Inc.K260178盆底肌肉训练器（KM510，KM516B）Shenzhen Konmed Technology Co., Ltd.K252601盆底肌肉训练器（PC22A）；盆底肌肉训练器（PC22A-L）；盆底肌肉训练器（PC22E）；盆底肌肉训练器（PC22E-L）Hunan Accurate Bio-Medical Technology Co., Ltd.K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.K252831Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd.K252334PELVIPOWER盆腔功能性磁刺激(PELVIPOWER盆腔FMS)(033-0-1100-02)Pontemedag
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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