免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

盆底肌肉训练器(KM510,KM516B)

K号: K260178 · 2026-06-18

决定日期2026-06-18
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

Pelvic Muscle Trainer (KM510, KM516B) 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 2026-06-18 under 510(k) number K260178. 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 Pelvic Muscle Trainer (KM510, KM516B)?

Pelvic Muscle Trainer (KM510, KM516B) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Shenzhen Konmed Technology Co., Ltd.. The 510(k) number is K260178.

When did Pelvic Muscle Trainer (KM510, KM516B) receive FDA 510(k) clearance?

Pelvic Muscle Trainer (KM510, KM516B) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K260178.

Who is the listed applicant for Pelvic Muscle Trainer (KM510, KM516B)?

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 Pelvic Muscle Trainer (KM510, KM516B)?

The FDA product code for Pelvic Muscle Trainer (KM510, KM516B) 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。

查看所有 7 个设备 →

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。

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。

↑