活力骨盆训练器
K号: K162689 · 2017-06-08
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决定日期2017-06-08
产品代码HIR
咨询委员会OB
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决定实质等同
器械摘要
Vibrance Pelvic Trainer is the device name listed in this FDA 510(k) record. The listed applicant is Bioinfinity (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K162689. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Vibrance Pelvic Trainer?
Vibrance Pelvic Trainer is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Bioinfinity (M) Sdn. Bhd.. The 510(k) number is K162689.
When did Vibrance Pelvic Trainer receive FDA 510(k) clearance?
Vibrance Pelvic Trainer received FDA 510(k) clearance on 2017-06-08, under 510(k) number K162689.
Who is the listed applicant for Vibrance Pelvic Trainer?
The FDA 510(k) record lists Bioinfinity (M) Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Vibrance Pelvic Trainer?
The FDA product code for Vibrance Pelvic Trainer is HIR.
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：HIR）
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。
K252748Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd.K240805Flyte机械治疗系统，MTI-1.5（MTI-1.5）Pelvital USA, Inc.K231875阴道触觉超声成像仪Advanced Tactile Imaging, Inc.K233362Flyte机械治疗系统（又称Flyte系统）（MTI-1.0）Pelvital USA, Inc.K231780Perifit Care+X6 InnovationsK221476PerifitX6 Innovations
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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