FDA 510(k)

leva 骨盆底训练器

K号: K180637 · 2018-04-04

决定日期2018-04-04

产品代码HIR

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决定实质等同

器械摘要

leva Pelvic Floor Trainer is the device name listed in this FDA 510(k) record. The listed applicant is Renovia, Inc.. It received FDA 510(k) clearance on 2018-04-04 under 510(k) number K180637. 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 leva Pelvic Floor Trainer?

leva Pelvic Floor Trainer is a medical device that received FDA 510(k) clearance on 2018-04-04. The listed applicant is Renovia, Inc.. The 510(k) number is K180637.

When did leva Pelvic Floor Trainer receive FDA 510(k) clearance?

leva Pelvic Floor Trainer received FDA 510(k) clearance on 2018-04-04, under 510(k) number K180637.

Who is the listed applicant for leva Pelvic Floor Trainer?

The FDA 510(k) record lists Renovia, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for leva Pelvic Floor Trainer?

The FDA product code for leva Pelvic Floor Trainer is HIR.

列明Renovia, Inc.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。

K213913莱瓦盆底健康系统 K212495Leva盆底健康系统 K192270LEva 盆腔数字健康系统

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