Pelvifine盆底肌肉训练器
K号: K163288 · 2018-01-18
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决定日期2018-01-18
产品代码KPI
咨询委员会GU
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决定实质等同
器械摘要
Pelvifine Pelvic Muscle Trainer is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Konmed Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-01-18 under 510(k) number K163288. 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 Pelvifine Pelvic Muscle Trainer?
Pelvifine Pelvic Muscle Trainer is a medical device that received FDA 510(k) clearance on 2018-01-18. The listed applicant is Shenzhen Konmed Technology Co., Ltd.. The 510(k) number is K163288.
When did Pelvifine Pelvic Muscle Trainer receive FDA 510(k) clearance?
Pelvifine Pelvic Muscle Trainer received FDA 510(k) clearance on 2018-01-18, under 510(k) number K163288.
Who is the listed applicant for Pelvifine Pelvic Muscle Trainer?
The FDA 510(k) record lists Shenzhen Konmed Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pelvifine Pelvic Muscle Trainer?
The FDA product code for Pelvifine Pelvic Muscle Trainer 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Shenzhen Konmed Technology Co., 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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