Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

leva Pelvic Floor Trainer

K-Number: K180637 · 2018-04-04

ApplicantRenovia, Inc.
Decision Date2018-04-04
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07687173Assessment of Effectiveness of Pelvic Floor Muscle Training With Biofeedback in Male With Hypogonadism and Erectile DysfunctionNOT_YET_RECRUITING

Other records listing Renovia, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213913leva Pelvic Health SystemK212495Leva Pelvic Health SystemK192270LEva Pelvic Digital Health System

Related Devices (Code: HIR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252748Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd.K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)Pelvital USA, Inc.K231875Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)Pelvital USA, Inc.K231780Perifit Care+X6 InnovationsK221476PerifitX6 Innovations

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑